Systems and methods relating to an analyte sensor system having a battery located within a disposable base

ABSTRACT

An analyte sensor system is provided. The system includes a base configured to attach to a skin of a host. The base includes an analyte sensor configured to generate a sensor signal indicative of an analyte concentration level of the host, a battery, and a first plurality of contacts. The system includes a sensor electronics module configured to releasably couple to the base. The sensor electronics module includes a second plurality of contacts, each configured to make electrical contact with a respective one of the first plurality of contacts, and a wireless transceiver configured to transmit a wireless signal based at least in part on the sensor signal. The system includes a first sealing member configured to provide a seal around the first and second plurality of contacts within a first cavity. Related analyte sensor systems, analyte sensor base assemblies and methods are also provided.

INCORPORATION BY REFERENCE TO RELATED APPLICATIONS

Any and all priority claims identified in the Application Data Sheet, orany correction thereto, are hereby incorporated by reference under 37CFR 1.57. This application is a continuation of U.S. application Ser.No. 16/403,037, filed May 3, 2019, which claims priority to U.S.Provisional Application No. 62/667,348, filed May 4, 2018. Each of theaforementioned applications is incorporated by reference herein in itsentirety, and each is hereby expressly made a part of thisspecification.

TECHNICAL FIELD

The present development relates generally to medical devices such asanalyte sensors, and more particularly, but not by way of limitation, tosystems, devices, and methods related to disposable analyte sensor baseshaving a battery disposed therein and reusable sensor electronicsmodules configure to releasably couple to the bases.

BACKGROUND

Diabetes is a metabolic condition relating to the production or use ofinsulin by the body. Insulin is a hormone that allows the body to useglucose for energy, or store glucose as fat.

When a person eats a meal that contains carbohydrates, the food isprocessed by the digestive system, which produces glucose in theperson's blood. Blood glucose can be used for energy or stored as fat.The body normally maintains blood glucose levels in a range thatprovides sufficient energy to support bodily functions and avoidsproblems that can arise when glucose levels are too high, or too low.Regulation of blood glucose levels depends on the production and use ofinsulin, which regulates the movement of blood glucose into cells.

When the body does not produce enough insulin, or when the body isunable to effectively use insulin that is present, blood sugar levelscan elevate beyond normal ranges. The state of having a higher thannormal blood sugar level is called “hyperglycemia.” Chronichyperglycemia can lead to a number of health problems, such ascardiovascular disease, cataract and other eye problems, nerve damage(neuropathy), and kidney damage. Hyperglycemia can also lead to acuteproblems, such as diabetic ketoacidosis—a state in which the bodybecomes excessively acidic due to the presence of blood glucose andketones, which are produced when the body cannot use glucose. The stateof having lower than normal blood glucose levels is called“hypoglycemia.” Severe hypoglycemia can lead to acute crises that canresult in seizures or death.

A diabetes patient can receive insulin to manage blood glucose levels.Insulin can be received, for example, through a manual injection with aneedle. Wearable insulin pumps are also available. Diet and exercisealso affect blood glucose levels. A glucose sensor can provide anestimated glucose concentration level, which can be used as guidance bya patient or caregiver.

Diabetes conditions are sometimes referred to as “Type 1” and “Type 2”.A Type 1 diabetes patient is typically able to use insulin when it ispresent, but the body is unable to produce sufficient amounts ofinsulin, because of a problem with the insulin-producing beta cells ofthe pancreas. A Type 2 diabetes patient may produce some insulin, butthe patient has become “insulin resistant” due to a reduced sensitivityto insulin. The result is that even though insulin is present in thebody, the insulin is not sufficiently used by the patient's body toeffectively regulate blood sugar levels.

Blood sugar concentration levels may be monitored with an analytesensor, such as a continuous glucose monitor. A wearable continuousglucose monitor may be powered by a battery that powers the sensor andother components, such as wireless communication circuitry. It isimportant that battery power be consistently available to assure thatanalyte concentration levels can be sensed and communicated by theanalyte sensor.

This Background is provided to introduce a brief context for the Summaryand Detailed Description that follow. This Background is not intended tobe an aid in determining the scope of the claimed subject matter nor beviewed as limiting the claimed subject matter to implementations thatsolve any or all of the disadvantages or problems presented above.

SUMMARY

According to some embodiments, an analyte sensor system is provided. Thesystem includes a base configured to attach to a skin of a host. Thebase includes an analyte sensor configured to generate a sensor signalindicative of an analyte concentration level of the host, a battery, anda first plurality of contacts. The system includes a sensor electronicsmodule configured to releasably couple to the base. The sensorelectronics module includes a second plurality of contacts, eachconfigured to make electrical contact with a respective one of the firstplurality of contacts, and a wireless transceiver configured to transmita wireless signal based at least in part on the sensor signal. Thesystem includes a first sealing member configured to provide a sealaround the first and second plurality of contacts within a first cavity.

In some embodiments, the base is disposable. In some embodiments, thesensor electronics module is reusable. In some embodiments, the batteryis configured to provide power to the analyte sensor and to the sensorelectronics module. In some embodiments, the first plurality of contactsincludes a first sensor contact and a second sensor contact, eachconfigured to be electrically coupled to a respective terminal of theanalyte sensor. In some embodiments, the second plurality of contactsincludes a first signal contact configured to make electrical contactwith the first sensor contact and a second signal contact configured tomake electrical contact with the second sensor contact.

In some embodiments, the first plurality of contacts further includes afirst battery contact and a second battery contact, each configured tobe electrically coupled to a respective terminal of the battery. In someembodiments, the second plurality of contacts further includes a firstpower contact configured to make electrical contact with the firstbattery contact and a second power contact configured to make electricalcontact with the second battery contact. In some embodiments, the firstand second signal contacts are configured to receive the sensor signalvia the first and second sensor contacts and the first and second powercontacts are configured to receive power from the battery.

In some embodiments, the base further includes a first retaining memberand a second retaining member, and the sensor electronics module furtherincludes a securement feature configured to mate with the firstretaining member and a retention feature configured to mate with thesecond retaining member, thereby releasably coupling the sensorelectronics module to the base. In some embodiments, the secondretaining member is frangible and configured to be separable from thebase.

In some embodiments, the base further includes a cover configured tosecure to the base and configured to secure the battery within the base.In some embodiments, the cover includes a first plurality of conductivetraces configured to couple at least some of the first plurality ofcontacts to one of the analyte sensor and the battery. In someembodiments, the cover includes a recess configured to receive thebattery. In some embodiments, the cover includes a weld line configuredto secure the cover to the base. In some embodiments, the first sealingmember is configured as a portion of the cover. In some embodiments, thecover is configured to be disposed between the base and the sensorelectronics module. In some embodiments, the cover is configured tosecure to a bottom of the base.

In some embodiments, the base includes a first plurality of conductivetraces configured to couple at least some of the first plurality ofcontacts to one of the analyte sensor and the battery. In someembodiments, the first sealing member extends over the first pluralityof conductive traces, thereby sealing the first plurality of conductivetraces from moisture ingress. In some embodiments, the first sealingmember extends over the battery, thereby sealing the battery frommoisture ingress. In some embodiments, at least some of the secondplurality of contacts are in direct electrical contact with the analytesensor or the battery.

In some embodiments, the second plurality of contacts are disposed onthe securement feature. In some embodiments, the second plurality ofcontacts include at least one signal contact configured to electricallyconnect with the analyte sensor and at least one power contactconfigured to electrically connect with the battery. In someembodiments, the second plurality of contacts include at least twosignal contacts configured to electrically connect with the analytesensor and at least two power contacts configured to electricallyconnect with the battery. In some embodiments, the first retainingmember includes a hood and the first plurality of contacts are disposedwithin the hood. In some embodiments, the first sealing member isdisposed around a circumference of the securement feature such that thefirst cavity is disposed within the hood. In some embodiments, the firstsealing member is disposed on an inner surface of the hood. In someembodiments, the sensor electronics module is configured to releasablycouple to the base by mating the securement feature with the firstretaining member while the sensor electronics module is disposed at anelevated angle with respect to the base, and pivoting the sensorelectronics module, about the first retaining member, toward the baseuntil the retention feature mates with the second retaining member.

In some embodiments, the sensor electronics module includes an apertureand the base includes a raised portion configured to fit within theaperture, an outer perimeter of the raised portion complimenting aninner perimeter of the aperture. In some embodiments, the firstplurality of contacts is disposed on the raised portion. In someembodiments, the aperture is symmetrical about at least one axisparallel to a top surface of the sensor electronics module andasymmetrical about at least one other axis parallel to the top surfaceof the sensor electronics module. In some embodiments, a top surface ofthe raised portion sits substantially flush with a top surface of thesensor electronics module. In some embodiments, the sensor electronicsmodule is configured to releasably couple to the base by fitting theraised portion of the base within the aperture of the sensor electronicsmodule and pressing the sensor electronics module against the base in adirection substantially perpendicular to a bottom surface of the baseuntil the one or more retention features of the sensor electronicsmodule couple with one or more corresponding retaining members of thebase. In some embodiments, the base includes a recess disposed in a topsurface of the base and the sensor electronics module includes aprotrusion configured to mate with the recess, thereby aligning thesensor electronics module with the base.

In some embodiments, the base further includes a third plurality ofcontacts, the sensor electronics module further includes a fourthplurality of contacts, each configured to make electrical contact with arespective one of the third plurality of contacts, and the systemfurther includes a second sealing member configured to provide acontinuous seal around the third and fourth plurality of contacts withina second cavity. In some embodiments, the third plurality of contactsincludes a first battery contact and a second battery contact, eachconfigured to be electrically coupled to a respective terminal of thebattery. In some embodiments, the fourth plurality of contacts includesa first power contact configured to make electrical contact with thefirst battery contact and a second power contact configured to makeelectrical contact with the second battery contact. In some embodiments,the second plurality of contacts include concentric, circular contacts.In some embodiments, the concentric, circular contacts are disposedaround a center of the sensor electronics module. In some embodiments,each of the second plurality of contacts are configured to makeelectrical contact with the respective one of the first plurality ofcontacts when the sensor electronics module is secured to the base inany of a plurality of radial orientations.

In some embodiments, the base includes an aperture and the sensorelectronics module includes a raised portion configured to fit withinthe aperture, an outer perimeter of the raised portion complimenting aninner perimeter of the aperture. In some embodiments, the aperture andthe raised portion each have a substantially circular shape. In someembodiments, the sensor electronics module is configured to releasablycouple to the base by fitting the raised portion of the sensorelectronics module within the aperture of the base and pressing thesensor electronics module against the base in a direction substantiallyperpendicular to a bottom surface of the base until the one or moreretention features of the sensor electronics module couple with one ormore corresponding retaining members of the base.

In some embodiments, the base includes a raised rail and the sensorelectronics module includes a channel having a shape that compliments ashape of the raised rail. In some embodiments, the raised rail has aconstant width along a length of the raised rail. In some embodiments, awidth of the raised rail tapers along a length of the raised rail. Insome embodiments, the first plurality of contacts is disposed on asidewall of the raised rail and the second plurality of contacts isdisposed on a sidewall of the channel. In some embodiments, the firstand third plurality of contacts are disposed on a sidewall of the baseand the second and fourth plurality of contacts are disposed on asidewall of the sensor electronics module. In some embodiments, thesensor electronics module is configured to releasably couple to the baseby aligning the channel of the sensor electronics module with the raisedrail of the base, and sliding the sensor electronics module, along theraised rail, in a direction parallel to the host's body until the sensorelectronics module is seated against the base, and one or more retentionfeatures of the sensor electronics module couple with one or morecorresponding retaining members of the base.

According to some embodiments, an analyte sensor system is provided. Thesystem includes a base configured to attach to a skin of a host. Thebase includes an analyte sensor configured to generate a sensor signalindicative of an analyte concentration level of the host, a battery, anda first plurality of contacts. The system includes a sensor electronicsmodule configured to releasably couple to the base. The sensorelectronics module includes a second plurality of contacts, eachconfigured to make electrical contact with a respective one of the firstplurality of contacts when the sensor electronics module is secured tothe base in any of a plurality of radial orientations, and a wirelesstransceiver configured to transmit a wireless signal based at least inpart on the sensor signal.

In some embodiments, the second plurality of contacts are concentric andannularly spaced apart from one another. In some embodiments, arespective one of the second plurality of contacts is configured to makeelectrical contact with the respective one of the first plurality ofcontacts at any point along the respective one of the second pluralityof contacts. In some embodiments, the second plurality of contacts areformed by laser direct structuring. In some embodiments, the systemfurther comprises a first sealing member configured to provide a sealaround the first and second plurality of contacts within a first cavity.

In some embodiments, the base is disposable. In some embodiments, thesensor electronics module is reusable. In some embodiments, the batteryis configured to provide power to the analyte sensor and to the sensorelectronics module. In some embodiments, the first plurality of contactscomprises a first sensor contact and a second sensor contact, eachconfigured to be electrically coupled to a respective terminal of theanalyte sensor. In some embodiments, the second plurality of contactscomprises a first signal contact configured to make electrical contactwith the first sensor contact and a second signal contact configured tomake electrical contact with the second sensor contact. In someembodiments, the first plurality of contacts further comprises a firstbattery contact and a second battery contact, each configured to beelectrically coupled to a respective terminal of the battery.

According to some embodiments, an analyte sensor base assembly isprovided. The assembly includes a base configured to attach to a skin ofa host. The assembly includes an analyte sensor configured to generate asensor signal indicative of an analyte concentration level of the host.The assembly includes at least one battery. The assembly includes atleast one sensor contact. The assembly includes at least one batterycontact. The assembly includes a sealing member configured to provide aseal around at least the at least one battery contact.

In some embodiments, the sealing member is further configured to providethe seal around at least the at least one sensor contact. In someembodiments, the assembly includes at least two sensor contacts and atleast two battery contacts, wherein the sealing member is configured toprovide the seal around the at least two sensor contacts and the atleast two battery contacts. In some embodiments, the base furtherincludes a plurality of conductive traces configured to electricallyconnect the battery to the at least one battery contact. In someembodiments, the base further includes a plurality of conductive tracesconfigured to electrically connect the analyte sensor to the at leastone sensor contact. In some embodiments, the assembly is disposable. Insome embodiments, the battery is configured to provide power to theanalyte sensor and to a sensor electronics module that is couplable tothe base.

In some embodiments, the base further includes a first retaining memberconfigured to mate with a securement feature of a couplable sensorelectronics module, and a second retaining member configured to matewith a retention feature of the couplable sensor electronics module. Insome embodiments, the second retaining member is frangible andconfigured to be separable from the base. In some embodiments, the basefurther includes a cover configured to secure to the base and configuredto secure the battery within the base. In some embodiments, the firstretaining member includes a hood and the at least one sensor contact andthe at least one battery contact are disposed within the hood. In someembodiments, the sealing member is disposed within the hood.

According to some embodiments, an analyte monitoring system is provided.The system may include a base configured to connect to a host, areusable portion, and a battery assembly. The base may include ananalyte sensor configured to detect a sensor signal indicative of ananalyte concentration level of the host. The reusable portion may beconfigured to couple to the base may include a wireless transceiver,wherein the reusable portion receives a signal from the base andtransmits a wireless signal based at least in part on the sensor signal.The battery assembly may include a battery housing and one or morebatteries. The battery assembly may be configured to mechanically couplewith the base or the reusable portion and electrically couple with thebase or the reusable portion, wherein the batteries deliver power to theanalyte sensor and the wireless transceiver.

According to some embodiments, an analyte monitoring kit is provided.The kit may include a sensor electronics package including a processorand a communication circuit, and a plurality of sensor devices, eachsensor device including a sensor device battery and a sensor configuredto generate a signal indicative of an analyte concentration level of ahost, wherein the sensor electronics package is configured toelectrically and mechanically couple with each of the plurality ofsensor devices and draw power from the sensor device battery to powerthe processor and the communication circuit, wherein the sensorelectronics package is reusable with the plurality of sensor devices.

According to some embodiments, a biosensor device is provided. Thedevice may include an analyte sensor configured to generate a signal asensor signal representative of a concentration level of a substance ina fluid of a host, a processor configured to receive the sensor signaland determine a value based on the sensor signal, a communicationcircuit operatively coupled to the processor and configured to transmitthe value based on the sensor signal, a battery, and a supercapacitorelectrically coupled to the battery, wherein the battery and thesupercapacitor are configured to deliver power to the processor or thecommunication circuit, the supercapacitor reducing a load on the batteryto reduce strain on the battery during a high-load period.

This summary is intended to provide an overview of subject matter of thepresent patent application. It is not intended to provide an exclusiveor exhaustive explanation of the disclosure. The detailed description isincluded to provide further information about the present patentapplication. Other aspects of the disclosure will be apparent to personsskilled in the art upon reading and understanding the following detaileddescription and viewing the drawings that form a part thereof, each ofwhich are not to be taken in a limiting sense.

BRIEF DESCRIPTION OF THE DRAWINGS

The present embodiments now will be discussed in detail with an emphasison highlighting the advantageous features. These embodiments are forillustrative purposes only and are not to scale, instead emphasizing theprinciples of the disclosure. These drawings include the followingfigures, in which like numerals may indicate like parts:

FIG. 1 is an illustration of an example medical device system, accordingto some embodiments;

FIG. 2 is a schematic illustration of various example electroniccomponents that may be part of the medical device system shown in FIG.1, according to some embodiments;

FIG. 3 is a flowchart illustration of an example method of managingpower consumption in an analyte monitoring system, according to someembodiments;

FIG. 4 is a flowchart illustration of an example method of managingpower output based upon monitored sensor values or performance metrics,according to some embodiments;

FIG. 5 is a flowchart illustration of an example method of selecting acommunication protocol based upon satisfaction of an analyte managementcondition, according to some embodiments;

FIG. 6 is a flowchart illustration of an example method of managingpower using an operational parameter received from a peripheral device,according to some embodiments;

FIG. 7A is a flowchart illustration of an example method of managingpower based upon user input, according to some embodiments;

FIG. 7B is a flowchart illustration of an example method of managingpower based upon a sleep command, according to some embodiments;

FIG. 8 is a flowchart illustration of an example method of determiningan operating protocol to assure battery life satisfies a specified timeparameter, according to some embodiments;

FIG. 9 is a flowchart illustration of an example method of usinginformation from a non-volatile memory after a power reset, according tosome embodiments;

FIG. 10A is a cross sectional view of an example sensor assembly,according to some embodiments;

FIG. 10B is an enlarged portion of the sensor assembly of FIG. 10A;

FIG. 11A is a perspective top view of an example sensor base, accordingto some embodiments;

FIG. 11B is a perspective bottom view of the base shown in FIG. 11A;

FIG. 12A is a perspective top view of an example sensor base, accordingto some embodiments;

FIG. 12B is a perspective bottom view of the base shown in FIG. 12A;

FIG. 13A is a perspective top view of an example sensor base, accordingto some embodiments;

FIG. 13B is a perspective bottom view of the base shown in FIG. 13A;

FIG. 14A is a perspective top view of an example sensor base, accordingto some embodiments;

FIG. 14B is a perspective bottom view of the base shown in FIG. 14A andan example sensor electronics module configured to mechanically andelectrically couple with the base shown in FIGS. 14A and 14B;

FIG. 15A is a perspective top view of an example sensor base, accordingto some embodiments;

FIG. 15B is a perspective bottom view of the base shown in FIG. 15A;

FIG. 16A is a perspective top view of an example sensor base, accordingto some embodiments;

FIG. 16B is a perspective bottom view of the base shown in FIG. 16A andan example sensor electronics module configured to mechanically andelectrically couple with the base shown in FIGS. 16A and 16B;

FIG. 17A is an exploded (disassembled) perspective top view of anexample sensor base and example sensor electronics module, according tosome embodiments;

FIG. 17B is a perspective view of the base shown in FIG. 17A assembledwith the sensor electronics module;

FIG. 18A is a perspective top view of an example sensor base, accordingto some embodiments;

FIG. 18B is an enlarged perspective view of the base shown in FIG. 17Aassembled with an example sensor electronics module;

FIG. 19A is a perspective top view of an example sensor base, accordingto some embodiments;

FIG. 19B is a perspective bottom view of the base shown in FIG. 19A andan example sensor electronics module configured to mechanically andelectrically couple with the base shown in FIGS. 19A and 19B;

FIG. 20A is a perspective top view of an example sensor base, accordingto some embodiments;

FIG. 20B is a perspective bottom view of the base shown in FIG. 20A andan example sensor electronics module configured to mechanically andelectrically couple with the base shown in FIGS. 20A and 20B;

FIG. 21A is a perspective top view of an example sensor base, accordingto some embodiments;

FIG. 21B is a perspective bottom view of the base shown in FIG. 21A andan example sensor electronics module configured to mechanically andelectrically couple with the base shown in FIGS. 21A and 21B;

FIG. 22A is a perspective top view of an example sensor base, accordingto some embodiments;

FIG. 22B is a perspective bottom view of the base shown in FIG. 22A;

FIG. 23A is a perspective view of an example base and a sensorelectronics module configured to be secured within the base, accordingto some embodiments;

FIG. 23B is a perspective view of the sensor electronics module securedto the base of FIG. 23A;

FIG. 23C is a plan view of the sensor electronics module secured to thebase of FIG. 23A;

FIG. 24A is a perspective view of a base including a cover having afrangible retaining member, according to some embodiments;

FIG. 24B is a perspective magnified view of a portion of the frangibleretaining member of FIG. 24A retaining a sensor electronics module tothe base, according to some embodiments;

FIG. 24C is a perspective view of the cover of FIG. 24A;

FIG. 24D is a perspective bottom view of the base of FIG. 24A;

FIG. 25A is an exploded perspective view of an example base and a sensorelectronics module configured to be secured within the base, accordingto some embodiments;

FIG. 25B is a plan view of the base of FIG. 25A;

FIG. 26A is an exploded perspective view of an example base and a sensorelectronics module configured to be secured within the base, accordingto some embodiments;

FIG. 26B is a plan view of the base of FIG. 26A;

FIG. 27A is an exploded perspective view of an example base and a sensorelectronics module configured to be secured within the base, accordingto some embodiments;

FIG. 27B is a plan view of the base of FIG. 27A;

FIG. 28A is a perspective view of an example base and a sensorelectronics module configured to be secured within the base, accordingto some embodiments;

FIG. 28B is a perspective view of the sensor electronics module securedto the base of FIG. 28A;

FIG. 28C is a plan view of the sensor electronics module secured to thebase of FIG. 28A;

FIG. 29A is an exploded perspective view of an example base and a sensorelectronics module configured to be secured within the base, accordingto some embodiments;

FIG. 29B is a perspective view of portions of the base of FIG. 29A;

FIG. 29C is a perspective view of a bottom of the base of FIG. 29A;

FIG. 30A is an exploded perspective view of an example base and a sensorelectronics module configured to be secured over or on the base,according to some embodiments;

FIG. 30B is a perspective assembled view of the sensor electronicsmodule secured to the base of FIG. 30A;

FIG. 31A is an exploded perspective view of an example base and a sensorelectronics module configured to be secured over or on the base,according to some embodiments;

FIG. 31B is a perspective view of a battery disposed on a cover of thebase of FIG. 31A;

FIG. 31C is a perspective bottom view of the base and the sensorelectronics module of FIG. 31A;

FIG. 32 is a perspective view of an example base and a sensorelectronics module configured to be secured over or on the base,according to some embodiments;

FIG. 33A is an exploded perspective view of an example base and a sensorelectronics module configured to be secured over or on the base,according to some embodiments;

FIG. 33B is a perspective view of a battery disposed on a cover of thebase of FIG. 33A;

FIG. 33C is an exploded perspective bottom view of the cover and thebase of FIG. 33B;

FIG. 33D is a perspective bottom view of the cover secured to the baseof FIG. 33B;

FIG. 34 is an exploded perspective view of an example base and a sensorelectronics module configured to be secured over or on the base,according to some embodiments;

FIG. 35A is an exploded perspective view of an example base and a sensorelectronics module configured to be secured over or on the base,according to some embodiments;

FIG. 35B is an exploded perspective bottom view of the base and thesensor electronics module of FIG. 35A;

FIG. 35C is a plan view of a bottom of the base of FIG. 35A;

FIG. 35D is a perspective cutaway view of the sensor electronics modulesecured to the base of FIG. 35A;

FIG. 36 is an exploded perspective view of an example base and a sensorelectronics module configured to be secured over or on the base,according to some embodiments;

FIG. 37A is an exploded perspective view of an example base and a sensorelectronics module configured to be secured over or on the base,according to some embodiments;

FIG. 37B is an exploded perspective bottom view of the base and thesensor electronics module of FIG. 37A;

FIG. 37C is a plan view of a bottom of the base of FIG. 37A;

FIG. 37D is a side cutaway view of the sensor electronics module securedto the base of FIG. 37A;

FIG. 38A is a perspective view of an example base and a sensorelectronics module configured to be slid over and secured to the base,according to some embodiments;

FIG. 38B is a perspective view of the sensor electronics module securedto the base of FIG. 38A;

FIG. 39A is a perspective view of an example base and a sensorelectronics module configured to be slid over and secured to the base,according to some embodiments;

FIG. 39B is another perspective view of the base of FIG. 39A;

FIG. 39C is an exploded perspective bottom view of the base and thesensor electronics module of FIG. 39A; and

FIG. 40 is a flowchart for a method for fabricating and/or manufacturingan analyte sensor system, according to some embodiments.

DETAILED DESCRIPTION

The following description and examples illustrate some exemplaryimplementations, embodiments, and arrangements in detail. Those of skillin the art will recognize that there are numerous variations andmodifications of this disclosure that are encompassed by its scope.Accordingly, the description of a certain example embodiment should notbe deemed to limit the scope of the present disclosure.

Definitions

In order to facilitate an understanding of the various embodimentsdescribed herein, a number of terms are defined below.

The term “analyte” as used herein is a broad term and is to be given itsordinary and customary meaning to a person of ordinary skill in the art(and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to a substance or chemicalconstituent in a biological fluid (for example, blood, interstitialfluid, cerebral spinal fluid, lymph fluid or urine) that can beanalyzed. Analytes can include naturally occurring substances,artificial substances, metabolites, and/or reaction products. In someembodiments, the analyte for measurement by the sensor heads, devices,and methods is analyte. However, other analytes are contemplated aswell, including but not limited to acarboxyprothrombin; acylcarnitine;adenine phosphoribosyl transferase; adenosine deaminase; albumin;alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle),histidine/urocanic acid, homocysteine, phenylalanine/tyrosine,tryptophan); andrenostenedione; antipyrine; arabinitol enantiomers;arginase; benzoylecgonine (cocaine); biotinidase; biopterin; c-reactiveprotein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholicacid; chloroquine; cholesterol; cholinesterase; conjugated 1-βhydroxy-cholic acid; cortisol; creatine kinase; creatine kinase MMisoenzyme; cyclosporin A; D-penicillamine; de-ethylchloroquine;dehydroepiandrosterone sulfate; DNA (acetylator polymorphism, alcoholdehydrogenase, alpha 1-antitrypsin, cystic fibrosis, Duchenne/Beckermuscular dystrophy, analyte-6-phosphate dehydrogenase, hemoglobin A,hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F,D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1,Leber hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax,sexual differentiation, 21-deoxycortisol); desbutylhalofantrine;dihydropteridine reductase; diptheria/tetanus antitoxin; erythrocytearginase; erythrocyte protoporphyrin; esterase D; fattyacids/acylglycines; free β-human chorionic gonadotropin; freeerythrocyte porphyrin; free thyroxine (FT4); free tri-iodothyronine(FT3); fumarylacetoacetase; galactose/gal-1-phosphate;galactose-1-phosphate uridyltransferase; gentamicin; analyte-6-phosphatedehydrogenase; glutathione; glutathione perioxidase; glycocholic acid;glycosylated hemoglobin; halofantrine; hemoglobin variants;hexosaminidase A; human erythrocyte carbonic anhydrase I;17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyl transferase;immunoreactive trypsin; lactate; lead; lipoproteins ((a), B/A-1, β);lysozyme; mefloquine; netilmicin; phenobarbitone; phenytoin;phytanic/pristanic acid; progesterone; prolactin; prolidase; purinenucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3);selenium; serum pancreatic lipase; sissomicin; somatomedin C; specificantibodies (adenovirus, anti-nuclear antibody, anti-zeta antibody,arbovirus, Aujeszky's disease virus, dengue virus, Dracunculusmedinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus,Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpesvirus, HIV-1, IgE (atopic disease), influenza virus, Leishmaniadonovani, leptospira, measles/mumps/rubella, Mycobacterium leprae,Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, parainfluenzavirus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa,respiratory syncytial virus, rickettsia (scrub typhus), Schistosomamansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosomacruzi/rangeli, vesicular stomatis virus, Wuchereria bancrofti, yellowfever virus); specific antigens (hepatitis B virus, HIV-1);succinylacetone; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine(T4); thyroxine-binding globulin; trace elements; transferrin;UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A;white blood cells; and zinc protoporphyrin. Salts, sugar, protein, fat,vitamins, and hormones naturally occurring in blood or interstitialfluids can also constitute analytes in certain embodiments. The analytecan be naturally present in the biological fluid, for example, ametabolic product, a hormone, an antigen, an antibody, and the like.Alternatively, the analyte can be introduced into the body, for example,a contrast agent for imaging, a radioisotope, a chemical agent, afluorocarbon-based synthetic blood, or a drug or pharmaceuticalcomposition, including but not limited to insulin; ethanol; cannabis(marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide,amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaine(crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin,Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine);depressants (barbituates, methaqualone, tranquilizers such as Valium,Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens(phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics(heroin, codeine, morphine, opium, meperidine, Percocet, Percodan,Tussionex, Fentanyl, Darvon, Talwin, Lomotil); designer drugs (analogsof fentanyl, meperidine, amphetamines, methamphetamines, andphencyclidine, for example, Ecstasy); anabolic steroids; and nicotine.The metabolic products of drugs and pharmaceutical compositions are alsocontemplated analytes. Analytes such as neurochemicals and otherchemicals generated within the body can also be analyzed, such as, forexample, ascorbic acid, uric acid, dopamine, noradrenaline,3-methoxytyramine (3MT), 3,4-Dihydroxyphenylacetic acid (DOPAC),Homovanillic acid (HVA), 5-Hydroxytryptamine (5HT), and5-Hydroxyindoleacetic acid (FHIAA).

The terms “microprocessor” and “processor” as used herein are broadterms and are to be given their ordinary and customary meaning to aperson of ordinary skill in the art (and are not to be limited to aspecial or customized meaning), and furthermore refer without limitationto a computer system, state machine, and the like that performsarithmetic and logic operations using logic circuitry that responds toand processes the basic instructions that drive a computer.

The term “calibration” as used herein is a broad term and is to be givenits ordinary and customary meaning to a person of ordinary skill in theart (and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to the process of determining therelationship between the sensor data and the corresponding referencedata, which can be used to convert sensor data into meaningful valuessubstantially equivalent to the reference data, with or withoututilizing reference data in real time. In some embodiments, namely, inanalyte sensors, calibration can be updated or recalibrated (at thefactory, in real time and/or retrospectively) over time as changes inthe relationship between the sensor data and reference data occur, forexample, due to changes in sensitivity, baseline, transport, metabolism,and the like.

The terms “calibrated data” and “calibrated data stream” as used hereinare broad terms and are to be given their ordinary and customary meaningto a person of ordinary skill in the art (and are not to be limited to aspecial or customized meaning), and furthermore refer without limitationto data that has been transformed from its raw state to another stateusing a function, for example a conversion function, including by use ofa sensitivity, to provide a meaningful value to a user.

The term “algorithm” as used herein is a broad term and is to be givenits ordinary and customary meaning to a person of ordinary skill in theart (and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to a computational process (forexample, programs) involved in transforming information from one stateto another, for example, by using computer processing.

The term “sensor” as used herein is a broad term and is to be given itsordinary and customary meaning to a person of ordinary skill in the art(and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to the component or region of adevice by which an analyte can be quantified. A “lot” of sensorsgenerally refers to a group of sensors that are manufactured on oraround the same day and using the same processes and tools/materials.Additionally, sensors that measure temperature, pressure etc. may bereferred to as a “sensor”.

The terms “glucose sensor” and “member for determining the amount ofglucose in a biological sample” as used herein are broad terms and areto be given their ordinary and customary meaning to a person of ordinaryskill in the art (and are not to be limited to a special or customizedmeaning), and furthermore refer without limitation to any mechanism(e.g., enzymatic or non-enzymatic) by which glucose can be quantified.For example, some embodiments utilize a membrane that contains glucoseoxidase that catalyzes the conversion of oxygen and glucose to hydrogenperoxide and gluconate, as illustrated by the following chemicalreaction:

Glucose+O₂→Gluconate+H₂O₂

Because for each glucose molecule metabolized, there is a proportionalchange in the co-reactant O₂ and the product H₂O₂, one can use anelectrode to monitor the current change in either the co-reactant or theproduct to determine glucose concentration.

The terms “operably connected” and “operably linked” as used herein arebroad terms and are to be given their ordinary and customary meaning toa person of ordinary skill in the art (and are not to be limited to aspecial or customized meaning), and furthermore refer without limitationto one or more components being linked to another component(s) in amanner that allows transmission of signals between the components. Forexample, one or more electrodes can be used to detect the amount ofglucose in a sample and convert that information into a signal, e.g., anelectrical or electromagnetic signal; the signal can then be transmittedto an electronic circuit. In this case, the electrode is “operablylinked” to the electronic circuitry. These terms are broad enough toinclude wireless connectivity.

The term “determining” encompasses a wide variety of actions. Forexample, “determining” may include calculating, computing, processing,deriving, investigating, looking up (e.g., looking up in a table, adatabase or another data structure), ascertaining and the like. Also,“determining” may include receiving (e.g., receiving information),accessing (e.g., accessing data in a memory) and the like. Also,“determining” may include resolving, selecting, choosing, calculating,deriving, establishing and/or the like. Determining may also includeascertaining that a parameter matches a predetermined criterion,including that a threshold has been met, passed, exceeded, and so on.

The term “substantially” as used herein is a broad term and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and is not to be limited to a special or customizedmeaning), and furthermore refers without limitation to being largely butnot necessarily wholly that which is specified.

The term “host” as used herein is a broad term and is to be given itsordinary and customary meaning to a person of ordinary skill in the art(and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to mammals, particularly humans.

The term “continuous analyte (or glucose) sensor” as used herein is abroad term and is to be given its ordinary and customary meaning to aperson of ordinary skill in the art (and is not to be limited to aspecial or customized meaning), and furthermore refers withoutlimitation to a device that continuously or continually measures aconcentration of an analyte, for example, at time intervals ranging fromfractions of a second up to, for example, 1, 2, or 5 minutes, or longer.In one exemplary embodiment, the continuous analyte sensor is a glucosesensor such as described in U.S. Pat. No. 6,001,067, which isincorporated herein by reference in its entirety.

The term “sensing membrane” as used herein is a broad term and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and is not to be limited to a special or customizedmeaning), and furthermore refers without limitation to a permeable orsemi-permeable membrane that can be comprised of two or more domains andis typically constructed of materials of a few microns thickness ormore, which are permeable to oxygen and may or may not be permeable toglucose. In one example, the sensing membrane comprises an immobilizedglucose oxidase enzyme, which enables an electrochemical reaction tooccur to measure a concentration of glucose.

The term “sensor data,” as used herein is a broad term and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and are not to be limited to a special or customizedmeaning), and furthermore refers without limitation to any dataassociated with a sensor, such as a continuous analyte sensor. Sensordata includes a raw data stream, or simply data stream, of analog ordigital signals directly related to a measured analyte from an analytesensor (or other signal received from another sensor), as well ascalibrated and/or filtered raw data. In one example, the sensor datacomprises digital data in “counts” converted by an A/D converter from ananalog signal (e.g., voltage or amps) and includes one or more datapoints representative of a glucose concentration. Thus, the terms“sensor data point” and “data point” refer generally to a digitalrepresentation of sensor data at a particular time. The terms broadlyencompass a plurality of time spaced data points from a sensor, such asfrom a substantially continuous glucose sensor, which comprisesindividual measurements taken at time intervals ranging from fractionsof a second up to, e.g., 1, 2, or 5 minutes or longer. In anotherexample, the sensor data includes an integrated digital valuerepresentative of one or more data points averaged over a time period.Sensor data may include calibrated data, smoothed data, filtered data,transformed data, and/or any other data associated with a sensor.

The term “sensor electronics,” as used herein, is a broad term, and isto be given its ordinary and customary meaning to a person of ordinaryskill in the art (and is not to be limited to a special or customizedmeaning) and refers without limitation to the components (for example,hardware and/or software) of a device configured to process data. Asdescribed in further detail hereinafter (see, e.g., FIG. 2) “sensorelectronics” may be arranged and configured to measure, convert, store,transmit, communicate, and/or retrieve sensor data associated with ananalyte sensor.

The terms “sensitivity” or “sensor sensitivity,” as used herein, arebroad terms, and are to be given their ordinary and customary meaning toa person of ordinary skill in the art (and is not to be limited to aspecial or customized meaning), and refer without limitation to anamount of signal produced by a certain concentration of a measuredanalyte, or a measured species (e.g., H₂O₂) associated with the measuredanalyte (e.g., glucose). For example, in one embodiment, a sensor has asensitivity from about 1 to about 300 picoamps of current for every 1mg/dL of glucose analyte.

The term “sample,” as used herein, is a broad term, and is to be givenits ordinary and customary meaning to a person of ordinary skill in theart (and it is not to be limited to a special or customized meaning),and refers without limitation to a sample of a host body, for example,body fluids, including, blood, serum, plasma, interstitial fluid,cerebral spinal fluid, lymph fluid, ocular fluid, saliva, oral fluid,urine, excretions, or exudates.

The term “distal to,” as used herein, is a broad term, and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and is not to be limited to a special or customized meaning)and refers without limitation to the spatial relationship betweenvarious elements in comparison to a particular point of reference. Ingeneral, the term indicates an element is located relatively far fromthe reference point than another element.

The term “proximal to,” as used herein, is a broad term, and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and is not to be limited to a special or customized meaning)and refers without limitation to the spatial relationship betweenvarious elements in comparison to a particular point of reference. Ingeneral, the term indicates an element is located relatively near to thereference point than another element.

The terms “electrical connection” and “electrical contact,” as usedherein, are broad terms, and are to be given their ordinary andcustomary meaning to a person of ordinary skill in the art (and are notto be limited to a special or customized meaning), and refer withoutlimitation to any connection between two electrical conductors known tothose in the art. In one embodiment, electrodes are in electricalconnection with (e.g., electrically connected to) the electroniccircuitry of a device. In another embodiment, two materials, such as butnot limited to two metals, can be in electrical contact with each other,such that an electrical current can pass from one of the two materialsto the other material and/or an electrical potential can be applied.

The term “elongated conductive body,” as used herein, is a broad term,and is to be given its ordinary and customary meaning to a person ofordinary skill in the art (and is not to be limited to a special orcustomized meaning), and refers without limitation to an elongated bodyformed at least in part of a conductive material and includes any numberof coatings that may be formed thereon. By way of example, an “elongatedconductive body” may mean a bare elongated conductive core (e.g., ametal wire), an elongated conductive core coated with one, two, three,four, five, or more layers of material, each of which may or may not beconductive, or an elongated non-conductive core with conductivecoatings, traces, and/or electrodes thereon and coated with one, two,three, four, five, or more layers of material, each of which may or maynot be conductive.

The term “ex vivo portion,” as used herein, is a broad term, and is tobe given its ordinary and customary meaning to a person of ordinaryskill in the art (and is not to be limited to a special or customizedmeaning), and refers without limitation to a portion of a device (forexample, a sensor) adapted to remain and/or exist outside of a livingbody of a host.

The term “in vivo portion,” as used herein, is a broad term, and is tobe given its ordinary and customary meaning to a person of ordinaryskill in the art (and is not to be limited to a special or customizedmeaning), and refers without limitation to a portion of a device (forexample, a sensor) adapted for insertion into and/or existence within aliving body of a host.

The term “potentiostat,” as used herein, is a broad term, and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and is not to be limited to a special or customized meaning)and refers without limitation to an electronic instrument that controlsthe electrical potential between the working and reference electrodes atone or more preset values.

The term “processor module,” as used herein, is a broad term, and is tobe given its ordinary and customary meaning to a person of ordinaryskill in the art (and are not to be limited to a special or customizedmeaning), and refers without limitation to a computer system, statemachine, processor, components thereof, and the like designed to performarithmetic or logic operations using logic circuitry that responds toand processes the basic instructions that drive a computer.

The term “sensor session,” as used herein, is a broad term and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and is not to be limited to a special or customizedmeaning), and refers without limitation to a period of time a sensor isin use, such as but not limited to a period of time starting at the timethe sensor is implanted (e.g., by the host) to removal of the sensor(e.g., removal of the sensor from the host's body and/or removal of(e.g., disconnection from) system electronics).

The terms “substantial” and “substantially,” as used herein, are broadterms, and are to be given their ordinary and customary meaning to aperson of ordinary skill in the art (and are not to be limited to aspecial or customized meaning) and refer without limitation to asufficient amount that provides a desired function.

“Coaxial two conductor wire-based sensor”: A round wire sensorconsisting of a conductive center core, an insulating middle layer and aconductive outer layer with the conductive layers exposed at one end forelectrical contact.

“Pre-connected sensor”: A sensor that has a “sensorinterconnect/interposer/sensor carrier” attached to it. Therefore this“Pre-connected sensor” comprises two parts that are joined: the sensoritself, and the interconnect/interposer/sensor carrier. The term“pre-connected sensor” unit refers to the unit that is formed by thepermanent union of these two distinct parts.

Other definitions will be provided within the description below, and insome cases from the context of the term's usage.

As employed herein, the following abbreviations apply: Eq and Eqs(equivalents); mEq (milliequivalents); M (molar); mM (millimolar) μM(micromolar); N (Normal); mol (moles); mmol (millimoles); μmol(micromoles); nmol (nanomoles); g (grams); mg (milligrams); μg(micrograms); Kg (kilograms); L (liters); mL (milliliters); dL(deciliters); μL (microliters); cm (centimeters); mm (millimeters); μm(micrometers); nm (nanometers); h and hr (hours); min. (minutes); s andsec. (seconds); ° C. (degrees Centigrade) ° F. (degrees Fahrenheit), Pa(Pascals), kPa (kiloPascals), MPa (megaPascals), GPa (gigaPascals), Psi(pounds per square inch), kPsi (kilopounds per square inch).

Overview

Energy in an analyte sensor system may be managed by controlling energyoutput, such as the consumption of energy by communication circuits orother circuits, and by controlling energy inputs, such as replacing orrecharging batteries. Wearable analyte sensor systems may include abattery, capacitor, or other power storage component, that powers asensor, processor, communication circuit, or other electricalcomponents. Management of energy consumption (e.g. power management,i.e. management of energy expended per unit of time) can be important toextend the life of sensor components (e.g., a battery) and to assurethat the analyte sensor continues to perform its intended function(s).For example, where a component (e.g., a sensor electronics module, whichmay include relatively costly wireless sensor electronics packagecomponents) has a battery that is not rechargeable or replaceable, thelife of the component may be extended by managing the use of energystored in the battery.

Sensor systems may apply algorithms that take into account one or moreof a variety of real-time, systemic, trend, model, or other factors suchas wireless performance, analyte management (e.g., glucose management),battery state, power management trends or characteristic, patient orenvironmental risk factors, risk tolerance, location, or a combinationthereof. For example, a system may take an action responsive to acondition. A system response may include changing system behavior todecrease power consumption or increase power consumption based on thedetermined condition. For example, an analyte management condition(e.g., estimated glucose level in range or below or above a specifiedvalue or exhibiting a specified trend) may be used as an input todetermine system behavior and energy consumption. In various examples, acondition may be predetermined and programmed or hard-wired into adevice, or specified by a user, or determined by a processor (e.g.,based upon information learned from data.)

In some examples, a sensor system may receive an operational parameterthat relates to a peripheral device, which may be a therapy device suchas an insulin pump or pen. The sensor system may receive the operationalparameter from the peripheral device, or from a remote resource based onan identification of the peripheral device (e.g., pump model number orserial number), or from a memory (e.g., retrieved from a lookup table.)The sensor system may manage its operations based at least in part onthe operational parameter. For example, based on the operationalparameter, a system may communicate according to a schedule, or with aspecified device or group of devices, or manage power consumption toextend a battery.

System hardware may be configured to enable replacement of batteries,and system components (e.g., sensor base and sensor electronics) may beconfigured to provide a water-tight seal after replacement of batteries.Battery-supporting technologies such as supercapacitors may also be usedto facilitate energy management.

Example System

FIG. 1 is an illustration of an example system 100. The system 100 mayinclude an analyte sensor system 102 that may be coupled to a host 101.The host 101 may be a human patient. The patient may, for example, besubject to a temporary or permanent diabetes condition or other healthcondition for which analyte monitoring may be useful.

The analyte sensor system 102 may include an analyte sensor 104, whichmay for example be a glucose sensor. The glucose sensor may be anydevice capable of measuring the concentration of glucose. For example,the analyte sensor 104 may be fully implantable, or the analyte sensormay be wearable on the body (e.g., on the body but not under the skin),or the analyte sensor may be a transcutaneous device (e.g., with asensor residing under or in the skin of a host). It should be understoodthat the devices and methods described herein can be applied to anydevice capable of detecting a concentration of glucose and providing anoutput signal that represents the concentration of glucose (e.g., as aform of analyte data).

The analyte sensor system 102 may also include sensor electronics 106.In some examples, the analyte sensor 104 and sensor electronics 106 maybe provided as an integrated package. In other examples, the analytesensor 104 and sensor electronics 106 may be provided as separatecomponents or modules. For example, the analyte sensor system 102 mayinclude a disposable (e.g., single-use) base that may include theanalyte sensor 104, a component for attaching the sensor to a host(e.g., an adhesive pad), or a mounting structure configured to receiveanother component. The system may also include a sensor electronicspackage, which may include some or all of the sensor electronics 106shown in FIG. 2. The sensor electronics package may be reusable.

An analyte sensor may use any known method, including invasive,minimally-invasive, or non-invasive sensing techniques (e.g., opticallyexcited fluorescence, microneedle, transdermal monitoring of glucose),to provide a data stream indicative of the concentration of the analytein a host. The data stream may be a raw data signal, which may beconverted into a calibrated and/or filtered data stream that is used toprovide a useful value of the analyte (e.g., estimated blood glucoseconcentration level) to a user, such as a patient or a caretaker (e.g.,a parent, a relative, a guardian, a teacher, a doctor, a nurse, or anyother individual that has an interest in the wellbeing of the host).

Analyte sensor 104 may, for example, be a continuous glucose sensor,which may, for example, include a subcutaneous, transdermal (e.g.,transcutaneous), or intravascular device. In some embodiments, such asensor or device may recurrently (e.g., periodically or intermittently)analyze sensor data. The glucose sensor may use any method ofglucose-measurement, including enzymatic, chemical, physical,electrochemical, spectrophotometric, polarimetric, calorimetric,iontophoretic, radiometric, immunochemical, and the like. In variousexamples, the analyte sensor system 102 may be or include a continuousglucose monitor sensor available from DexCom™ (e.g., the DexCom G5™sensor or Dexcom G6™ sensor or any variation thereof.)

In some examples, analyte sensor 104 may be an implantable glucosesensor, such as described with reference to U.S. Pat. No. 6,001,067 andU.S. Patent Publication No. US-2005-0027463-A1. In some examples,analyte sensor 104 may be a transcutaneous glucose sensor, such asdescribed with reference to U.S. Patent Publication No.US-2006-0020187-A1. In some examples, analyte sensor 104 may beconfigured to be implanted in a host vessel or extracorporeally, such asis described in U.S. Patent Publication No. US-2007-0027385-A1,co-pending U.S. Patent Publication No. US-2008-0119703-A1 filed Oct. 4,2006, U.S. Patent Publication No. US-2008-0108942-A1 filed on Mar. 26,2007, and U.S. Patent Application No. US-2007-0197890-A1 filed on Feb.14, 2007. In some examples, the continuous glucose sensor may include atranscutaneous sensor such as described in U.S. Pat. No. 6,565,509 toSay et al., for example. In some examples, analyte sensor 104 may be acontinuous glucose sensor that includes a subcutaneous sensor such asdescribed with reference to U.S. Pat. No. 6,579,690 to Bonnecaze et al.or U.S. Pat. No. 6,484,046 to Say et al., for example. In some examples,the continuous glucose sensor may include a refillable subcutaneoussensor such as described with reference to U.S. Pat. No. 6,512,939 toColvin et al., for example. The continuous glucose sensor may include anintravascular sensor such as described with reference to U.S. Pat. No.6,477,395 to Schulman et al., for example. The continuous glucose sensormay include an intravascular sensor such as described with reference toU.S. Pat. No. 6,424,847 to Mastrototaro et al., for example.

The system 100 may also include a second medical device 108, which may,for example, be a drug delivery device (e.g., insulin pump or insulinpen). In some examples, the medical device 108 may be or include asensor, such as another analyte sensor, a heart rate sensor, arespiration sensor, a motion sensor (e.g. accelerometer), posture sensor(e.g. 3-axis accelerometer), acoustic sensor (e.g. to capture ambientsound or sounds inside the body). In some examples, medical device 108may be wearable, e.g. on a watch, glasses, contact lens, patch,wristband, ankle band, or other wearable item, or may be incorporatedinto a handheld device (e.g., a smartphone). In some examples, themedical device 108 may include a multi-sensor patch that may, forexample, detect one or more of an analyte level (e.g. glucose, lactate,insulin or other substance), heart rate, respiration (e.g., usingimpedance), activity (e.g. using an accelerometer), posture (e.g. usingan accelerometer), galvanic skin response, tissue fluid levels (e.g.using impedance or pressure).

The analyte sensor system 102 may communicate with the second medicaldevice 108 via a wired connection, or via a wireless communicationsignal 110. For example, the analyte sensor system may be configured tocommunicate using via radio frequency (e.g. Bluetooth, Medical ImplantCommunication System (MICS), WiFi, NFC, RFID, Zigbee, Z-Wave or othercommunication protocols), optically (e.g. infrared), sonically (e.g.ultrasonic), or a cellular protocol (e.g., CDMA (Code Division MultipleAccess) or GSM (Global System for Mobiles), or wired connection (e.g.serial, parallel, etc.). In some examples, an array or network ofsensors may be associated with the patient. For example, the analytesensor system 102, medical device 108, and an additional sensor 130 maycommunicate with one another via wired or wireless (e.g., Bluetooth,MICS, or any of the other options discussed above,) communication. Theadditional sensor 130 may be any of the examples discussed above withrespect to medical device 108. The analyte sensor system 102, medicaldevice 108, and additional sensor 130 on the host 101 are provided forthe purpose of illustration and discussion and are not necessarily drawnto scale.

The system may also include one or more peripheral devices, such as ahand-held smart device (e.g., smartphone) 112, tablet 114, smart pen 116(e.g., insulin delivery pen with processing and communicationcapability), computer 118, watch 120, or peripheral medical device 122,any of which may communicate with the analyte sensor system 102 via awireless communication signal, and may also communicate over a network124 with a server system (e.g., remote data center) 126 or with a remoteterminal 128 to facilitate communication with a remote user (not shown)such as a technical support staff member or a clinician.

The system 100 may also include a wireless access point (WAP) 132 thatmay be used to communicatively couple one or more of analyte sensorsystem 102, network 124, server system 126, medical device 108 or any ofthe peripheral devices described above. For example, WAP 132 may provideWi-Fi and/or cellular connectivity within system 100. Othercommunication protocols (e.g., Near Field Communication (NFC) orBluetooth) may also be used among devices of the system 100. In someexamples, the server system 126 may be used to collect analyte data fromanalyte sensor system 102 and/or the plurality of other devices, and toperform analytics on collected data, generate or apply universal orindividualized models for glucose levels, and communicate suchanalytics, models, or information based thereon back to one or more ofthe devices in the system 100.

FIG. 2 is a schematic illustration of various example electroniccomponents that may be part of a medical device system 200. In anexample, the system may include a sensor electronics 106 and a base 290.While a specific example of division of components between the base andsensor electronics is shown, it is understood that some examples mayinclude additional components in the base 290 or in the sensorelectronics 106, and the some of the components (e.g., supercapacitor284) that are shown in the sensor electronics 106 may be alternative oradditionally (e.g., redundantly) provided in the base. In an example,the base 290 may include the analyte sensor 104 and a battery 292. Insome examples, the base may be replaceable, and the sensor electronics106 may include a debouncing circuit (e.g., gate with hysteresis ordelay) to avoid, for example, recurrent execution of a power-up or powerdown process when a battery is repeatedly connected and disconnected oravoid processing of noise signal associated with removal or replacementof a battery.

The sensor electronics 106 may include electronics components that areconfigured to process sensor information, such as sensor data, andgenerate transformed sensor data and displayable sensor information. Thesensor electronics 106 may, for example, include electronic circuitryassociated with measuring, processing, storing, or communicatingcontinuous analyte sensor data, including prospective algorithmsassociated with processing and calibration of the sensor data. Thesensor electronics module 106 may include hardware, firmware, and/orsoftware that enables measurement of levels of the analyte via a glucosesensor. Electronic components may be affixed to a printed circuit board(PCB), or the like, and can take a variety of forms. For example, theelectronic components may take the form of an integrated circuit (IC),such as an Application-Specific Integrated Circuit (ASIC), amicrocontroller, and/or a processor.

As shown in FIG. 2, the sensor electronics 106 may include apotentiostat 202, which may be coupled to the analyte sensor 104 andconfigured to recurrently obtain analyte sensor readings using theanalyte sensor, for example by continuously or recurrently placing avoltage bias across sensor electrodes and measuring a current flowindicative of analyte concentration. The sensor electronics may alsoinclude a processor 204, which may retrieve instructions 206 from memory208 and execute the instructions to determine control application ofbias potentials to the analyte sensor 104 via the potentiostat,interpret signals from the sensor, or compensate for environmentalfactors. The processor may also save information in data storage memory210 or retrieve information from data storage memory 210. In variousexamples, data storage memory 210 may be integrated with memory 208, ormay be a separate memory circuit, such as a non-volatile memory circuit(e.g., flash RAM). Examples of systems and methods for processing sensoranalyte data are described in more detail herein and in U.S. Pat. Nos.7,310,544 and 6,931,327.

The sensor electronics 106 may also include a sensor 212, which may becoupled to the processor. The sensor 212 may, for example, be atemperature sensor or an accelerometer. The sensor electronics 106 mayalso include a power source such as a capacitor or battery 214, whichmay be integrated into the sensor electronics, or may be removable, orpart of a separate electronics package. The battery 214 (or other powerstorage component, e.g., capacitor) may optionally be rechargeable via awired or wireless (e.g., inductive or ultrasound) recharging system 216.The recharging system may harvest energy or may receive energy from anexternal source or on-board source. In various examples, the rechargecircuit may include a triboelectric charging circuit, a piezoelectriccharging circuit, an RF charging circuit, a light charging circuit, anultrasonic charging circuit, a heat charging circuit, a heat harvestingcircuit, or a circuit that harvests energy from the communicationcircuit. In some examples, the recharging circuit may recharge therechargeable battery using power supplied from a replaceable battery(e.g., a battery supplied with a base component.)

The sensor electronics may also include one or more supercapacitors 284in the sensor electronics package (as shown), or in the base. Forexample, the supercapacitor 284 may allow energy to be drawn from thebattery in a highly consistent manner to extend a life of the battery.The battery may recharge the supercapacitor after the supercapacitordelivers energy to the communication circuit or to the processor, sothat the supercapacitor is prepared for delivery of energy during asubsequent high-load period. In some examples, the supercapacitor may beconfigured in parallel with the battery. A device may be configured topreferentially draw energy from the supercapacitor, as opposed to thebattery. In some examples, a supercapacitor may be configured to receiveenergy from the rechargeable battery for short-term storage and transferenergy to the rechargeable battery for long-term storage.

The supercapacitor may extend an operational life of the battery byreducing the strain on the battery during the high-load period. In someexamples, a supercapacitor removes at least 10% of the strain off thebattery during high-load events. In some examples, a supercapacitorremoves at least 20% of the strain off the battery during high-loadevents. In some examples, supercapacitor removes at least 30% of thestrain off the battery during high-load events. In some examples, asupercapacitor removes at least 50% of the strain off the battery duringhigh-load events.

The sensor electronics 106 may also include a wireless communicationcircuit 218, which may for example include a wireless transceiveroperatively coupled to an antenna. The wireless communication circuit218 may be operatively coupled to the processor and may be configured towirelessly communicate with one or more peripheral devices or othermedical devices, such as an insulin pump or smart insulin pen.

Peripheral device 250 may include, a user interface 252, a memorycircuit 254, a processor 256, a wireless communication circuit 258, asensor 260, or any combination thereof. The user interface 252 may, forexample, include a touch-screen interface, a microphone (e.g., toreceive voice commands), or a speaker, a vibration circuit, or anycombination thereof, which may receive information from a user (e.g.,glucose values) or deliver information to the user such as glucosevalues, glucose trends (e.g., an arrow, graph, or chart), or glucosealerts. The processor 256 may be configured to present information to auser, or receive input from a user, via the user interface 252. Theprocessor 256 may also be configured to store and retrieve information,such as communication information (e.g., pairing information or datacenter access information), user information, sensor data or trends, orother information in the memory circuit 254. The wireless circuitcommunication circuit 258 may include a transceiver and antennaconfigured communicate via a wireless protocol, such as Bluetooth, MICS,or any of the other options discussed above. The sensor 260 may, forexample, include an accelerometer, a temperature sensor, a locationsensor, biometric sensor, or blood glucose sensor, blood pressuresensor, heart rate sensor, respiration sensor, or other physiologicsensor. The peripheral device 250 may, for example, be devices such as ahand-held smart device (e.g., smartphone or other device such as aproprietary handheld device available from Dexcom) 112, tablet 114,smart pen 116, watch 120 or other wearable device, or computer 118 shownin FIG. 1.

The peripheral device 250 may be configured to receive and displaysensor information that may be transmitted by sensor electronics module106 (e.g., in a customized data package that is transmitted to thedisplay devices based on their respective preferences). Sensorinformation (e.g., blood glucose concentration level) or an alert ornotification (e.g., “high glucose level”, “low glucose level” or “fallrate alert” may be communicated via the user interface 252 (e.g., viavisual display, sound, or vibration). In some examples, the peripheraldevice 250 may be configured to display or otherwise communicate thesensor information as it is communicated from the sensor electronicsmodule (e.g., in a data package that is transmitted to respectivedisplay devices). For example, the peripheral device 250 may transmitdata that has been processed (e.g., an estimated analyte concentrationlevel that may be determined by processing raw sensor data), so that adevice that receives the data may not be required to further process thedata to determine usable information (such as the estimated analyteconcentration level.) In other examples, the peripheral device 250 mayprocess or interpret the received information (e.g., to declare an alertbased on glucose values or a glucose trend. In various examples, theperipheral device 250 may receive information directly from sensorelectronics 106, or over a network (e.g., via a cellular or Wi-Finetwork that receives information from the sensor electronics or from adevice that is communicatively coupled to the sensor electronics 106.)

Referring again to FIG. 2, the medical device 270 may include a userinterface 272, a memory circuit 274, a processor 276, a wirelesscommunication circuit 278, a sensor 280, a therapy circuit 282, or anycombination thereof. The user interface 272 may, for example, include atouch-screen interface, a microphone, or a speaker, a vibration circuit,or any combination thereof, which may receive information from a user(e.g., glucose values, alert preferences, calibration coding) or deliverinformation to the user, such as e.g., glucose values, glucose trends(e.g., an arrow, graph, or chart), or glucose alerts. The processor 276may be configured to present information to a user, or receive inputfrom a user, via the user interface 272. The processor 276 may also beconfigured to store and retrieve information, such as communicationinformation (e.g., pairing information or data center accessinformation), user information, sensor data or trends, or otherinformation in the memory circuit 274. The wireless circuitcommunication circuit 278 may include a transceiver and antennaconfigured communicate via a wireless protocol, such as Bluetooth,Medical Implant Communication System (MICS), Wi-Fi, Zigbee, or acellular protocol (e.g., CDMA (Code Division Multiple Access) or GSM(Global System for Mobiles). The sensor 280 may, for example, include anaccelerometer, a temperature sensor, a location sensor, biometricsensor, or blood glucose sensor, blood pressure sensor, heart ratesensor, respiration sensor, or other physiologic sensor. The medicaldevice 270 may include two or more sensors (or memories or othercomponents), even though only one is shown in the example in FIG. 2. Invarious examples, the medical device 270 may be a smart handheld glucosesensor (e.g., blood glucose meter), drug pump (e.g., insulin pump), orother physiologic sensor device, therapy device, or combination thereof.The medical device 270 may be the device 122 shown in FIG. 1.

In examples where the medical device 122 or medical device 270 is aninsulin pump, the pump and analyte sensor system may be in two-waycommunication (e.g., so the pump can request a change to an analytetransmission protocol, e.g., request a data point or request data on amore frequency schedule, and the analyte sensor system provides therequested data accordingly), or the pump and analyte sensor system maycommunicate using one-way communication (e.g., the pump may receiveanalyte concentration level information from the analyte sensor system,for example, not in response to a request. In one-way communication, aglucose value may be incorporated in an advertisement message, which maybe encrypted with a previously-shared key. In a two-way communication, apump may request a value, which the analyte system may share, or obtainand share, in response to the request from the pump, and any or all ofthese communications may be encrypted using one or morepreviously-shared keys. An insulin pump to may receive and track analyte(e.g., glucose) values transmitted from analyte sensor system 102 usingone-way communication to the pump for one or more of a variety ofreasons. For example, an insulin pump may suspend or activate insulinadministration based on a glucose value being below or above a thresholdvalue.

In some examples, the system 100 shown in FIG. 1 may include two or moreperipheral devices that each receive information directly or indirectlyfrom the analyte sensor system 102. Because different display devicesprovide may different user interfaces, the content of the data packages(e.g., amount, format, and/or type of data to be displayed, alarms, andthe like) may be customized (e.g., programmed differently by themanufacture and/or by an end user) for each particular device. Forexample, in the embodiment of FIG. 1, a plurality of differentperipheral devices may be in direct wireless communication with a sensorelectronics module (e.g., such as an on-skin sensor electronics module106 that is physically connected to the continuous analyte sensor 104)during a sensor session to enable a plurality of different types and/orlevels of display and/or functionality associated with the displayablesensor information, or, to save battery power in the sensor system 102,one or more specified devices may communicate with the analyte sensorsystem and relay (i.e., share) information to other devices directly orthrough a server system (e.g., network-connected data center) 126.

Example Methods

FIG. 3 is a flowchart illustration of an example method 300 of managingpower consumption in an analyte monitoring system. The method may, forexample, include modulating power output from a first communicationcircuit to increase range or bandwidth by increasing power output and toconserve energy by decreasing power output from the first communicationcircuit. The method may, for example, be implemented in a system asshown in FIG. 1 or a device as shown in FIG. 2. The method may berepeated continuously or recurrently (e.g. periodically) or responsiveto one or more events to manage power on an ongoing basis.

At 302, a signal representative of an analyte (e.g., glucose)concentration level may be received. The signal may be received, forexample, from an analyte sensor, which may, for example, be a portion ofa continuous glucose monitoring system as described above.

At 304, a determination is made as to whether a first condition issatisfied. In some examples, a processor operatively coupled to ananalyte sensor (e.g., CGM processor) may determine whether the firstcondition is satisfied. In some examples, a processor in a peripheraldevice (e.g., smart phone or other display device) may determine whetherthe first condition is satisfied. Responsive to the condition not beingsatisfied, the method may return to step 302 and continue to receiveanalyte concentration levels.

In some examples, the first condition may be a connectivity condition,and step 304 may include determining whether the connectivity conditionhas been satisfied. The connectivity condition may, for example, includethe existence of a connection (e.g. Bluetooth connection), a reliabilityof a connection (e.g., based upon the occurrence of successfulconnection attempts, or based on connection failures), or a quality ofthe connection based on one or more signal strength measurementparameters (e.g., a received signal strength indicator (RSSI.))Determining whether the first condition is satisfied may includeapplying a connectivity parameter to a model. The model may include aplurality of communication states. The communication states may, forexample, be based upon reliability of communication, elapsed time withconsecutive successful communication sessions, elapsed time since anunsuccessful attempt (or series of attempts) to establish communication,or other measures of communication effectiveness or reliability.

The first condition may additionally or alternatively include an analytemanagement condition, such as a range (e.g., a glucose value range) or atrend (e.g. one or more analyte (glucose) levels being above or below aspecified value or within a specified range, or a rate of change ofanalyte concentration levels being above or below a rate-of-changethreshold.) In various examples, determining whether the first conditionis satisfied may include analyzing the analyte signal, or an analyteparameter based on the analyte signal, to determine whether the analytemanagement condition is satisfied.

In some examples, determining whether a first condition is satisfiedmay, for example, include applying an analyte parameter to a model(e.g., a state model). In some examples, the condition may correspond torecognition of a state of disease management that is clinically relevantto the user of a peripheral device. A condition may, for example, bebased upon by an analyte level (e.g. low estimated glucose level or highestimated glucose level), a trend (e.g., analyte concentration levelrate of change or a predictive data), a deviation from a trend (e.g.,reversal of a trend), or a probability of a clinically relevantcondition occurring in the future (e.g., urgent low glucose soon).

In some examples, a condition may correspond to or be based upon one ormore requirements of a peripheral device, such as an insulin pump. Forexample, a connectivity state may go from a low power usage model to ahigh-power usage model based upon a basal or bolus insulin deliverconditions (e.g., a high-power usage model or more reliable or frequencycommunication may be used when insulin is being delivered to avoid lossof a connection.)

In some examples, a state model may include a plurality of analyteconcentration level states. An analyte concentration level state may bedefined or determined by an analyte concentration range or trend (e.g.,glucose below target range, glucose in target range, or glucose abovetarget range.)

In some examples, a state model may additionally or alternativelyinclude a plurality of communication states (e.g., low power state, highpower state or high-reliability state, partnered state to coordinatewith a peripheral device such as a pump, battery life extension state toassure that predicted battery life meets a battery life criterion.)

Responsive to the condition being satisfied, the method 300 may include,at 306, shifting from a first wireless communication mode to a secondwireless communication mode responsive to satisfaction of a condition.In some examples, shifting from the first wireless communication mode tothe second wireless communication mode includes reducing power outputfrom a communication circuit to save energy. In some examples, the firstwireless communication mode may consume more power than the secondwireless communication mode. This shift to the second wirelesscommunication mode may allow an analyte monitoring system to save powerwhen the first condition is satisfied by shifting to the second wirelesscommunication mode. In some examples, a system may balance need forcommunication and power consumption. For example, satisfaction of thefirst condition may be associated with a less urgent need forcommunication (e.g., a determination that analyte concentration levelsand/or trends are in a “managed” range or state), in which case lessfrequent (e.g. on 15-minute intervals instead of 5-minute intervals),less power-demanding (e.g. lower transmit power or lower powerprotocol), or less automatic or on-demand communication (e.g. NFCinstead of Bluetooth) communication may be acceptable. In some examples,a processor may monitor power consumption continuously or recurrentlyintermittently or may increase or decrease power consumption responsiveto a protocol or satisfaction of a condition.

In some examples, the second wireless communication mode uses less powerthan the first wireless communication mode. In some examples, the firstwireless communication mode may be a continuous connection mode asdefined by a connection protocol (e.g., Bluetooth) and the secondwireless communication mode may be a periodic connection mode. Theperiodic connection mode may require fewer wireless transmissionsrequired to maintain an active state (e.g. based on a minimum connectioninterval) than the continuous connection mode. In some examples, thefirst wireless communication mode may be a two-way communication modeand the second wireless communication mode may be a one-waycommunication mode that includes data transmission from the firstcommunication circuit. For example, the one-way communication mode maybe a broadcast mode (e.g., in a Bluetooth protocol.) The one-waycommunication protocol may require less time actively transmitting andreceiving, and therefore uses less power.

In some examples, the first wireless communication mode has a longerrange than the second wireless communication mode. For example, thefirst communication mode may include a medium to long range wirelesscommunication method or technology (e.g. Bluetooth or MICScommunication), and the second communication mode may use a short-rangewireless method or technology (e.g. NFC or inductive communication).Bluetooth tends to have a relatively long range (e.g., up to 100 m).MICS also tends to have a relatively long range (e.g., up to about 6 m),but the MICS range is usually shorter than Bluetooth. NFC and otherinductive communication techniques tend to have a relatively short range(e.g., 4 cm up to about 30 cm), but require less power, no power, and insome examples can harvest power.

In some examples, an authentication process may be performed in thefirst communication mode (e.g., in a two-way communication scheme toallow for exchange of keys), and the system may shift to the secondcommunication mode after authentication. In some examples, the systemmay transmit encrypted broadcast data via the second wirelesscommunication mode. The encrypted broadcast data may, for example,include analyte concentration level information, trend information, orstate information. In some examples, the encrypted broadcast data may beused to determine whether to shift from the second wirelesscommunication mode to the first wireless communication mode (e.g., todetermine whether the second condition is satisfied.) In some examples,the encrypted broadcast data may include an indication to shift backfrom the second wireless communication mode to the first wirelesscommunication mode. For example, an analyte system processor (e.g., CGMprocessor) may apply an algorithm to determine whether to shift back tothe first mode (e.g., back to two-way communication), and the peripheraldevice may transmit a bit flag in the broadcast packet. In someexamples, a peripheral device (e.g., smart phone or other handhelddisplay device) may apply an algorithm to determine whether to shiftfrom the first mode to the second mode (e.g., to save power.)

After shifting to the second wireless communication mode, the method mayinclude at 308 transmitting using the second wireless communication modefor a period of time, or until the satisfaction of a second condition(e.g., as determined at step 310.)

At 310, the method may include determining whether a second condition issatisfied. The second condition may be a different condition or may bean inverse of the first condition (e.g., an analyte level or trendmoving out of range or otherwise satisfying or failing to satisfy aglucose management condition, or failure to satisfy a communicationcondition.) When the second condition is not satisfied, the method mayreturn to transmitting the wireless signal using the second (e.g.,low-power) wireless communication mode at 308.

Responsive to the second condition being satisfied, the method mayinclude ceasing to use the second wireless communication mode. Forexample, when the second condition is satisfied, the method may include,at 312, shifting from a second wireless communication mode to the firstwireless communication mode. In some examples, the method 300 mayinclude shifting from the second communication mode back to the firstcommunication mode includes increasing power output to increasecommunication range or bandwidth, and, at 314, communicating using thefirst wireless communication mode. Alternatively, the method may at 310include shifting to a third wireless communication mode (e.g., to anintermediate power-consuming mode (e.g., intermittent two-waycommunication), or to a high-priority communication mode (e.g.,continuous connection) that may consume more power than the first mode)and communicating using the third wireless communication mode at 314.

In some examples, the method 300 may include shifting from a one-waycommunication mode (e.g., broadcast) to a two-way communication modewhen a sensor calibration is needed or to acknowledge that an alert oralarm has been received.

FIG. 4 is a flowchart illustration of an example method 400 of managingpower output based upon monitored sensor values or performance metrics.The method may be implemented, for example, in a system as shown in FIG.1 or a device as shown in FIG. 2.

The method 400 may include, at 402, monitoring one or more physiologicsensor values (e.g., analyte concentration level, temperature, activitylevel, heart rate.). The physiologic sensor values may, for example, bereceived from a wearable sensor device that includes an analyte sensor(e.g., analyte sensor) and a communication circuit. The wearable sensordevice may, for example, includes an analyte monitor, and the one ormore physiologic sensor values include an estimated analyteconcentration level.

The method may also include, at 404, monitoring one or morecommunication performance metrics pertaining to communication to or fromthe wearable sensor device. The communication performance metrics may,for example, include packet capture rates or received signal strengthindicator values.

The method may further include, at 406, determining whether a conditionis satisfied. The determination may, for example, be based at least inpart upon the monitored physiologic sensor values (e.g., satisfaction ofan analyte management condition) or the communication performancemetrics (e.g., satisfaction of a communication reliability condition),or both or a combination thereof. For example, the method may includedetermining whether an analyte management condition is satisfied basedat least in part on the estimated analyte concentration level. Theanalyte risk management condition may, for example, include a range, atrend, a projected analyte level, or other analyte managementinformation. As described in detail above, the condition may correspondto recognition of a state of disease management that is clinicallyrelevant to a user of a peripheral device

The method may additionally or alternatively include determining whethera communication reliability condition is satisfied based at least inpart on the communication performance metrics, and responsive todetermining that the communication reliability condition is satisfied,conserving power by shifting to a more energy efficient communicationscheme, or maintaining a current communication scheme (e.g., refrainingfrom increasing power output). The communication reliability conditionmay, for example, be based on signal strength or packet rate fallingbelow a threshold, or a combination thereof.

In some examples, the system may maintain the status quo (e.g., make nochange) when a condition is satisfied. In some examples, a condition maybe a negative condition, e.g., a negative condition may be satisfiedwhen some combination of requirements is not met.

Responsive to the satisfaction of a condition, the method may furtherinclude, at 408, increasing or decreasing power output of thecommunication circuit. In some examples, the method may include shiftingto a lower-power protocol. For example, the method may include shiftingfrom a long-range communication protocol to a short-range communicationprotocol (e.g., MICS or Bluetooth to NFC), or from a continuouslyconnected mode to a recurrently (e.g., periodically) connected mode, orfrom a two-way communication protocol to a one-way communication mode(e.g., broadcast mode.) In some examples, the method may includechanging one or more communication parameters (e.g., shifting thecommunication mode). In some examples, the method may includeperiodically communicating the estimated analyte concentration level toanother device and increasing or decreasing power output may includedecreasing a frequency of communication of the estimated analyteconcentration level.

In some example, increasing or decreasing power output may includeshifting a frequency, shifting a mode, shifting a power level, orshifting a time period between communications, to increase communicationrange or reliability, or to conserve energy. For example, a system mayshift between communicating one or more of once a minute, once everyfive minutes, once every ten minutes, or once every 30 minutes.

In some examples, increasing or decreasing power output may includerestricting communication to a specified peripheral device of aplurality of available peripheral devices (e.g., increasing power to apump but not to a smart watch). In some examples, the method may furtherinclude determining a specified peripheral device based on a schedule, apriority scheme, or a location. In some examples, the method may furtherinclude determining a battery status, wherein a communication scheme ismodified based at least in part on the monitored physiologic sensorvalues, the communication performance metrics, and the battery status.

FIG. 5 is a flowchart illustration of an example method 500 of selectinga communication protocol based upon satisfaction of an analytemanagement condition. The method 500 may, for example, be applied to ananalyte monitoring system including a communication circuit and ananalyte sensor configured to generate a signal representative of ananalyte concentration level, a processor configured to control operationof the system, and a battery configured to power the system. The methodmay be implemented, for example, in a system as shown in FIG. 1 or adevice as shown in FIG. 2.

The method may include, at 502, receiving an analyte managementcondition from a partner device, such as an insulin pump or an insulinpen. The analyte management condition may include, for example, a rangeof analyte concentration levels (e.g., glucose concentration levels), arate or change, or other parameter based on one or more analyteconcentration levels. In various examples, the analyte managementcondition may be determined by the partner device or may be input by auser of the partner device.

At 504, the method 500 may further include receiving, e.g., from ananalyte sensor, an analyte signal representative of an analyteconcentration level (e.g., glucose concentration level.) The method 500may also include, at 506, determining an analyte parameter based atleast in part upon the analyte signal. For example, an estimated analyteconcentration level (e.g., estimated glucose concentration level) may bedetermined. The method 500 may further include, at 508, determining awhether the analyte management condition is satisfied. The determinationmay be based at least in part on the analyte parameter. For example, themethod may include determining whether an estimated analyteconcentration level falls below a threshold, or exceeds a threshold, ora rate of change exceeds a rate of change threshold, or a predictedanalyte concentration level meets a condition (e.g., above or below athreshold.) In some examples, determining whether the analyte managementcondition is satisfied may include applying the analyte parameter to amodel (e.g., state model). The model may be predefined or may be learnedfrom data, and may reside in the system (e.g., in the sensorelectronics) or locally (e.g., on a smart device on or near the patient(host), or may reside on a remote system (e.g., on a networkedresource.) One or more parameters (e.g., an analyte parameter) may beapplied to the model (e.g., provided as input) and a state may bedetermined by applying the one or more parameters to the model. Thestate may, for example, relate to the host, such as a glucose state(e.g., in range, out of range, or trend) or may relate to communications(e.g., reliable or unreliable), or a combination thereof.

The method 500 may further include determining a communication protocolfor communicating with the partner device based at least in part onwhether the analyte management condition is satisfied. For example, themethod may include, at 510 communicating via a first communication mode(e.g., power level, frequency, protocol) when the condition issatisfied, and, at 512, communicating via second communication mode whenthe condition is not satisfied. In an example, when an estimated analytelevel (e.g., estimated glucose level) falls within a safe zone (e.g., 80to 140 mg/DL), which may be specified by a partner device (e.g., insulinpump) or based upon a requirement or characteristic of the partnerdevice, an analyte monitor (e.g., CGM) may communicate (e.g., advertisein a Bluetooth protocol) less frequently (e.g., every 15 or 30 minutesinstead of continuously or every 1 or 5 minutes) to conserve power, ormay shift to a one-way communication scheme, or may otherwise controloperation of the system conserve power as described herein.

FIG. 6 is a flowchart illustration of an example method 600 of managingpower using an operational parameter received from a peripheral device.The method 600 may be implemented in an analyte monitoring system (e.g.,CGM) including a communication circuit, an analyte sensor configured togenerate a signal representative of an analyte concentration level, aprocessor configured to control operation of the system, and a batteryconfigured to power the system. The method may, for example, beimplemented in a system as shown in FIG. 1 or a device as shown in FIG.2.

The method 600 may include, at 602, receiving via the communicationcircuit an operational parameter relating to a peripheral device. Theperipheral device may, for example, include a drug pump, a smart pen, ahandheld device (e.g., smart phone) or another type of display devicethat is configured to communicate with the analyte monitoring system.The operational parameter may be received from the peripheral device, orthe operational parameter may be received from a remote resource (e.g.,a server) or local device (e.g., smartphone app). In some examples, theoperational parameter may be retrieved from a memory circuit based uponan identity or characteristic of the peripheral device (e.g., retrievedfrom a lookup table.) In an example, a system may communicate with aperipheral device and receive (or exchange) device identificationinformation, and the system may then provide the device identificationinformation (e.g., via a device such as a smart phone) and receive theoperational parameter, which may be received from or determined by aremote resource (e.g., network server) or by a smart device.

In various examples, the operational parameter may, for example, includea battery management parameter, a calibration schedule parameter, asensor accuracy parameter, or contextual information. In some examples,the operational parameter may include contextual information from theperipheral device (e.g., information about an interaction of theperipheral device with another device or a network environment.) Forexample, the operational parameter may include information about aconnection state of the peripheral device (e.g., a network or remoteserver (“cloud”) connection, RSSI, or a missed communication). In someexamples, the operational parameter may include a status of theperipheral device, such as a battery level, an activity level (e.g.,determined using an accelerometer on the peripheral device), location(e.g., GPS or based on network connection status or strength), displaystatus (e.g., on or off), alert state (e.g., alert active or notactive), alert acknowledged (e.g., input received from user toacknowledge receipt of alert), use mode (e.g., open loop or closedloop), or status of a pending event or action (e.g., waiting for anaction or event.)

The method may further include, at 604, operating a system (e.g.,analyte monitoring system such as a CGM) based at least in part upon theoperational parameter. In various examples, a determination may be madebased on the operational parameter, the system may be operated based atleast in part on the determination. For example, the system maydetermine whether the operational parameter is within acceptable bounds.In some examples, the system may, for example, determine whether ananalyte concentration is a defined analyte concentration range orsatisfies a trend criterion, such as an average rate of change beingbelow a threshold value.

In some examples, the operational parameter may include an operationalrequirement of the peripheral device. The method 600 may includecontrolling operation of the system to satisfy the operationalrequirement.

In an example, the operational requirement may include a sensor accuracyrequirement and the system may be controlled to satisfy the sensoraccuracy requirement (e.g., calibrate or replace a sensor that does notsatisfy the sensor accuracy requirement). In an example, the operationalrequirement may include a calibration schedule, and the system may beoperated to satisfy the calibration schedule (e.g., a system may prompta user for calibrations to satisfy the schedule received from a partnerdevice).

In an example, the operational requirement may include a battery liferequirement, and the system may be operated to satisfy the battery liferequirement (e.g., the system may suggest replacement of a battery, or atransceiver or other component that contains a battery, to assure thatthe battery life requirement is satisfied.) In some examples, theoperational parameter may include a specified period of time (e.g., apump session time), and operation of a system (e.g., continuous analytesensor) may be controlled to manage energy consumption from the battery(e.g., analyte sensor battery) so that energy stored in the battery isnot depleted before the specified period of time expires, e.g., theprocessor may control operation of the communication circuit in a mannercalculated to assure that energy stored in the battery is not depletedbefore the specified period of time expires. For example, the processormay modify a communication scheme to conserve battery energy during thespecified period of time. For example, the processor may shift to acommunication mode that consumes less energy (e.g., shift from MICS orBluetooth to NFC, shift from an always connected mode to a recurrent(e.g., periodic) communication mode, or shift from a two-waycommunication mode to a one-way (e.g., broadcast) communication mode.

In some examples, a system (e.g., analyte monitoring system) may beconfigured to communicate with a second device (e.g., in addition to aperipheral device such as a pump or smart pen), and the method mayinclude restricting communication by the communication circuit so thatthe system communicates only with the peripheral device during thespecified period of time. For example, the system may receive awhitelist (e.g., from the peripheral device or from a smart device ornetwork resource) that the system may use during the specified period oftime. In another example, the system (e.g., analyte monitoring system)may receive an operational parameter that indicates that the system mayonly communicate with the peripheral device during a specified period oftime (e.g., the parameter may prescribe a communication schedule toreduce a need to broadcast). In another example, the system (e.g.,analyte monitoring system) may receive an operational parameter thatindicates that the system may communicate only with the peripheraldevice (e.g., with no other devices) during a specified period of time(e.g., to assure that a communication to a pump is successful). Inanother example, the system may receive an operational parameter toblacklist a communication device, such as a device that was previouslyconnected with the system (e.g., a previous pump that was replaced maybe blacklisted.)

In some examples, the operational parameter may include a specifiednumber of additional peripheral devices, and the method may includecommunicating only with the peripheral device and the specified numberof additional devices, wherein excessive consumption of energy stored inthe battery is avoided by limiting the number of devices with which theanalyte monitoring system communicates.

In some examples, the operational parameter may include anidentification of one or more additional peripheral devices, and themethod may include communicating only with the identified one or moreadditional devices, wherein excessive consumption of energy stored inthe battery is avoided by limiting the number of devices with which theanalyte monitoring system communicates. For example, an analytemonitoring system may communicate with a default or user-specifiedprimary device. In some examples, the identification may specify aspecific device, e.g., using a device ID. In some examples, theidentification may specify a type of device (e.g. a watch). Types ofperipheral devices may include, for example, a handheld device (e.g.,smartphone), a watch, a tablet, a pen, a pump, or a desktop computer.

In some examples, a system (e.g., analyte monitoring system) may receiveinformation about connections between peripheral devices. For example,an analyte system may receive information that a smart phone is incommunication with a watch. Responsive to receiving information that afirst peripheral device is in communication with a second peripheraldevice, the system may restrict communication to a specified device orgroup of devices (e.g., an analyte monitoring system may communicatewith a smart phone, or smartphone and pump) and rely on the specifieddevice to communicate with a third device (e.g., the smartphone may passinformation to a smartwatch to reduce battery consumption by an analytesensor system.)

In some examples, an operational parameter may be a schedule forproviding information such as an analyte level or trend (or both), and asystem may communicate according to the schedule. For example, ananalyte signal representative of an analyte concentration level may bereceived from an analyte sensor, processed to determine an estimatedanalyte concentration level, and transmitted via a wireless signal(e.g., using a communication circuit) according to a schedule specifiedby the operational parameter.

In some examples, a system (e.g., analyte monitoring system) may receivean identification (e.g., list) of one or more authorized peripheraldevices. The system may accept operational parameters or communicationrequests from one or more peripheral devices based upon theidentification of authorized devices.

FIG. 7A is a flowchart illustration of an example method 700 of managingpower based upon user input. In some examples, the method 800 may beimplemented in a system that may include an analyte sensor configured togeneration a signal indicative of an analyte concentration level in ahost, a processor configured to determine an estimated analyteconcentration level based on the signal, a communication circuitconfigured to transmit the estimated analyte concentration level orinformation based on the estimated analyte concentration level via atransmitted communication signal, and to receive user input via adetected communication signal. The system may be configured to control amode of communication for the communication circuit based at least inpart on the user input. The system may, for example, be the system 200shown in FIG. 2.

At 702, user input is received. The user input may be received directly,e.g., via a user interface (e.g., a graphical user interface GUI) or maybe received from another device (e.g., a smart phone or other smartdevice) that may receive the user input via a user interface. In oneexample, the user interface may include menus and buttons (e.g.,providing various options as described below), and the user may provideinputs via selecting the options from the menu and pressing the buttons.In some examples, the user input may be received over a network. Forexample, a host (e.g., child) to which an analyte sensor (e.g., glucosesensor) is attached may be in a first location, and the user (e.g., acaregiver) may provide the user input at a second location (e.g., via asmart phone) and the input may be relayed over a network (e.g., cellularnetwork or the internet) to a smart device that is near the host.

The user input may, for example, include a request to initiate anenergy-saving mode. The user input may also relate to energy management,e.g., the user input may include a request to align an estimated batterylife with a parameter of a partner device (e.g., a pump session.) Insome examples, the user input may include a specified condition. In someexamples, responsive to satisfaction of the specified condition, thesystem may communicate less frequently or take other steps to consumeless energy. In other examples, the system may enter a low-powerconsumption mode, and over-ride the low-power consumption moderesponsive to satisfaction of the specified condition (e.g., estimatedglucose level moving out of a safe range, or initiation of delivery ofbasal or bolus insulin by a pump.)

At 704, a sensor signal may be received from an analyte sensor. Thesensor signal may, for example, be indicative of an analyteconcentration level in a host (e.g., indicative of a glucoseconcentration.) The sensor signal may be received, for example, by aprocessor 204 as shown in FIG. 2 from an analyte sensor 104.

At 706, an estimated analyte concentration level (e.g., estimatedglucose concentration level) is determined based on the sensor signal.

At 708, an operational mode of the communication circuit may bedetermined based at least in part on the user input. The determinedoperational mode may, for example, be an energy-saving mode, in whichpower consumption by the communication circuit or by the system may bereduced. The system may invoke any of the methods described herein toconserve or manage energy expenditure (e.g., the system may communicateless frequently than in a normal mode of operation or limit the numberof devices with which the system communicates or communicate using alow-power technique (e.g., NFC) for non-critical communications or forall communications or for all communications.)

At 710, the estimated analyte concentration level, or information basedon the estimated analyte concentration level, may be transmitted via thecommunication circuit using the determined operational mode.Transmitting using the energy-saving mode include, for example,transmitting information less often than in a normal operating mode, ortransmitting using a less power-intensive mode of communication (e.g.,NFC as opposed to Bluetooth), or communicating with fewer devices (e.g.,communicating with a pump but not a watch), or communication via aperipheral device (e.g., communicating with a watch through asmartphone.

In some examples, a communication circuit may be controlled based atleast in part on the analyte concentration level.

In some examples, a system (e.g., CGM system) may determine whether acondition is satisfied based at least in part on the analyteconcentration level and control operation of the communication circuitto decreasing power consumption by the communication circuit based uponthe determination of whether the condition is satisfied. For example,the condition may include range of analyte concentration levels, anddetermining whether the condition is satisfied may include determiningwhether the determined analyte concentration level falls within therange of analyte concentration levels. In an example, when an analyteconcentration level is well controlled (e.g., estimated glucose levelbetween 80 and 150 mg/dL and steady (e.g., no rapid rate of change)), asystem may communicate less frequently that when an analyteconcentration level is not well controlled (e.g., estimated glucoselevel beyond a specified threshold, e.g., below 70 mg/DL or over 150mg/dL or 200 mg/DL or 250 mg/DL, or rising or falling quickly or acombination thereof.)

In some examples, the condition may include a trend condition, anddetermining whether the condition is satisfied may include determiningwhether the trend condition is satisfied using a plurality of analyteconcentration levels. For example, a trend condition may include ananalyte concentration level rate of change being below a specifiedthreshold (e.g., estimated glucose rate of change not more than 2mg/dL/minute or not more than 3 mg/dL/minute). The trend condition mayalso include an analyte concentration level (e.g., estimated glucoseconcentration level rate of change not more than 2 mg/dL per minute whenthe estimated glucose concentration level is less than 120 mg/dL.

In some examples, transmitting using the determined operational mode mayinclude decreasing power consumption by refraining from automatictransmission of analyte concentration information, or transmittinganalyte concentration information less often. In some examples,transmitting using the determined operational mode may includetransmitting only in response to a request (e.g., shift to a “pull” modeinstead of “push” mode), or transmitting less often unless a request isreceived (e.g., a request from a partner device or a user.)

In some examples, a determined operational mode may be overridden tocommunicate responsive to an analyte concentration level falling below athreshold or outside a range.

In some examples, the user input may include a specification of acondition, and the operation of the communication circuit may bemodified responsive to satisfaction of the condition. The condition may,for example, includes a range of analyte concentration levels or ananalyte trend condition, or any other condition discussed herein.

In some examples, a patient state may be determined based upon one ormore analyte concentration levels, and operation of the communicationcircuit may be modified to reduce power consumption responsive to thepatient state satisfying a safety condition. For example, a patientstate may be determined by applying one or more analyte concentrationlevels to a model, such as a state model that may include one or morestates determined by the model responsive to analyte concentrationslevel(s), and optionally also determined by contextual factors orinformation about the device (e.g., battery level) or an informationabout partner device (e.g., a pump.)

In some examples, the user input may include a request to operate thesystem in a manner to assure that an estimated battery life matches orexceeds an operation parameter relating to a partner device. Forexample, the operational parameter may be a period of time (e.g., a pumpsession time), and the system may operate the in a manner to extend thelife of a battery in the system so that the battery does not expire(e.g., be depleted to a charge level that is insufficient to perform afunction) before the period of time expires.)

In some examples, the system may monitor for an alert condition based atleast in part upon the estimated analyte concentration level and thesystem may override the energy savings mode to communicate an alert.

In some examples, a determined operational mode of communication mayinclude a hibernation mode (e.g., low-power consumption mode). In thehibernation mode, a system may stop communication, or may communicateonly very infrequently, or may only list but not transmit, or transmitvery unfrequently, or one or more non-communication operations (e.g.,sensing) may be suspended, or any combination thereof. In some examples,a system may enter a hibernation mode responsive to a user input thatincludes a request to stop a sensor session, or responsive to a requestto start a sensor session (e.g., because after starting a session asensor may not be used during a warm-up period in which the host/sensoradapts to the insertion of a sensor into the host). In some examples,the system may shift out of the hibernation mode after a specifiedperiod of time (e.g., after expiration of a warm-up period.)

FIG. 7B is a flowchart illustration of an example method 700 of managingpower based upon a sleep command (e.g., an instruction to enter ahibernation mode or other low-power consumption state.) The method maybe applied, for example, to an analyte monitoring system including acommunication circuit and an analyte sensor configured to generate asignal representative of an analyte concentration level, a processorconfigured to control operation of the system, and a battery configuredto power the system. The method may be implemented, for example, in asystem as shown in FIG. 1 or a device as shown in FIG. 2.

The method 770 may include, at 772, receiving via the communicationcircuit a sleep command from a peripheral device. It may be desirable,for example, to cause an analyte monitoring system to sleep during awarm up period (e.g., after application of a sensor to a host, a warm-upperiod may be required before sensor readings begin.) The method 770 mayinclude, at 774, shifting the system into a low-power state responsiveto receipt of the sleep command. In some examples, the system may stopcommunicating in a sleep state. For example, a communication circuitsmay stop sending and receiving completely for a period of time, or thecommunication circuit may enter a listening-only mode, which mayoptionally involve a lower-power listening mode than normal operation(e.g., longer duty cycles or wake up and listen on a schedule.) In someexamples, other portions of a system may also stop consuming energy orenter a low-power mode. For example, analyte sensor may stop applying asensing voltage to an electrode or a processor may stop collecting orprocessing data. In another example, when the system is in the low powermode, the analyte sensor may still continue to apply voltage for analytemeasurement purposes, however, the transmission/communication circuitmay remain in the sleep or low power mode. Yet, in another example, whensensor electronics are removed from a host (e.g., when a transmitter isdisconnected from a sensor), the sensor electronics may stop processingor communicating (e.g., because the sensor electronics are not receivingsensor data anyway.)

The method may include, at 776, waking the system from the low powerstate. In some examples, the system may include a clock that triggers awake-up event when a period of time (e.g., warm-up period) expires,e.g., using a timer or at a specified time. In some examples, the methodmay include waking the analyte monitoring system in response to awake-up command, e.g., in response to a command from a peripheral devicesuch as a pump or a smart device (e.g., smart phone or proprietaryhand-held device)

FIG. 8 is a flowchart illustration of an example method 800 ofdetermining an operating protocol to assure battery life satisfies aspecified time parameter. The method may be applied, for example, to ananalyte monitoring system that includes a communication circuit and ananalyte sensor configured to generate a signal representative of ananalyte concentration level, a processor configured to control operationof the system, and a battery configured to power the system. The methodmay be implemented, for example, in a system as shown in FIG. 1 or adevice as shown in FIG. 2.

The method 800 may include, at 802, receiving a specified time parameterfrom a peripheral device. The specified time parameter may, for example,be a specified time, such as a specific date (e.g., date, week, ormonth), or an amount of time, such as a number of days, weeks, ormonths. The method 800 may further include, at 804 determining an amountof energy remaining in a battery, e.g. based upon a voltage measurement,a current measurement, a coulomb counter, or any combination thereof.The method 800 may further include, at 806, determining a systemoperating protocol calculated to assure that projected energyconsumption by providing an estimated battery life that satisfies thespecified time parameter. For example, a projected energy consumptionrate may be determined based on one or more communication parameters(e.g., strength of transmissions, how often the system communicates, orhow many devices with which the system will communicate), one or moredata processing parameters (e.g., how much data processing will occur,and how often it will occur), one or more sensing parameters (e.g., howoften a sensor reading will be obtained), or any combination thereof. Inan example, the lifetime or expiration of an analyte sensor system(e.g., CGM) may be aligned with or extended to exceed the lifetime orexpiration of a pump, e.g., a CGM may be operated to assure that thebattery life of the CGM outlast the battery life of the pump or changingof a pump insertion site. In some examples, the system may assure thatenough battery remains at the end of the session to perform one or moreend-of-session tasks, such as transferring data to an external devicesuch as a smartphone. In some examples, a notification may be deliveredto a user to change or check an analyte sensor system battery tocoordinate battery replacement with pump replacement or insertion sitechange.

FIG. 9 is a flowchart illustration of an example method 900 of usinginformation from a non-volatile memory after a power reset. The methodmay be implemented, for example, in a system as shown in FIG. 1 or adevice as shown in FIG. 2.

The method 900 may include, at 902, receiving a sensor signalrepresentative of an analyte concentration level from a wearable analytemonitor. The method 900 may further include, at 904, recurrently storinginformation in a nonvolatile memory in preparation for an unplannedpower reset, such as when a removeable battery is removed from a device.The stored information may include, for example, an estimated analyteconcentration level determined from the sensor signal, and an associatedtime stamp. In some examples, the method 900 may also include storingtime data, session data, pairing information, reset counts, or batteryeffects of resets in the nonvolatile memory. A reset count and effect ofresets may be accounted for in an estimation of battery life remaining.

In some examples, periodically storing information may include storingcritical information. Critical information may be used to reestablish asession after a power reset and continue the session according tooperating parameters that were in use prior to the power reset. Forexample, a mode (e.g., communication mode, operating mode of a device,or mode of interaction with a peripheral device such as a pump) orstatus (e.g., analyte trend or patient status) may be resumed after apower reset.

The method 900 may further include, at 906, retrieving the storedinformation from the nonvolatile memory after a power reset. In someexamples, the method may further include initiating a power-up modeafter a power reset and using the stored information to assess devicestatus or an analyte status in the power-up mode. In some examples, adebouncing circuit (e.g., gate with hysteresis) may be used to avoidrecurrent execution of a power-up or power down process when a batteryis repeatedly connected and disconnected or avoid processing of noisesignal associated with removal or replacement of a battery. In someexamples, a system may execute instructions to remove noise associatedwith removal or insertion of a battery. For example, a system or devicemay detect connection or disconnection of a battery, and the system maydelay a power up or power-down process or delay processing of a signalfor a specified period of time after a connection or disconnection fromthe battery is detected. In some examples, a system or device may delaya power-down process for a specified period of time after a connectionto a battery is detected, which may allow the system or device to avoidsuccessive execution of power-up and power-down processes when a batteryis connected and disconnected multiple times in a short time window.

The method may further include, at 908, resuming operating using theretrieved information. In some examples, the method may further includedetermining an operating mode based at least in part on the storedinformation. In some examples, the determined operating mode may includeone or more of a power consumption mode or a communication mode. Forexample, the system may determine using stored information whether tooperate in a low power operating mode, normal operating mode (e.g.,default), or high-power operating mode (e.g., high frequencycommunication or high power to assure range or high probably ofcommunication success, which may be useful for example when the patientis in an unmanaged condition, e.g., in or trending toward a high glucosestate or low glucose state.)

In some examples, a low-power mode may be initiated based on a batterycondition (e.g., based on current, voltage, or remaining energy) or theamount of battery life remaining (e.g., time until expiration orestimated time until satisfaction of an end-of-life condition). Invarious examples, the low-power mode may conserve power by communicatingless often, or shifting to from a first communication mode or protocolto a second mode or protocol that uses less power (e.g., shift fromBluetooth to NFC), or communicating with fewer devices, or relying on aperipheral device to communicate with another device (e.g., engaging asmartphone to communicate to a watch, pump, or smart pen), or performinga non-communication operation (e.g., sensing) less often, or offloadingprocessing to a peripheral device (e.g., rely on a smartphone forcomplex processing). In some example, the determination of whether tooperate in the low-power mode after a power reset may be based uponbattery power after reset (e.g., to detect whether a battery withsufficient power (e.g., new battery) has been inserted, or whether alow-power battery (e.g., the same battery as was removed, or anotherlow-power battery) has been inserted. In some example, a power levelassessment (e.g., decision whether to operate in a low-power mode) maybe triggered after a power reset based upon information stored beforethe reset (e.g., based on one or more of the mode of operation beforereset, or an analyte management condition (e.g., glucose level ortrend), or communication condition (e.g., reliable or not) orcommunication mode (e.g. 2-way or 1-way.))

In some examples, the method may include determining an analyte trend abased at least in part on an estimated analyte concentration levelretrieved from the nonvolatile memory.

In some examples, the method may include periodically saving firstinformation on a first schedule and periodically saving additionalinformation on a second schedule, the first information being saved morefrequently than the additional information. For example, informationthat is critical for resuming a session after a power reset may be savedmore frequently than other types of information.

Example Battery and Device Structures

FIG. 10A is a cross sectional view of an example sensor assembly 1000.The sensor assembly 1000 may include a base 1002 that may include amounting unit 1004 that is configured to couple with a sensorelectronics module 1006, which may be or include the sensor electronicsmodule 106 of FIGS. 1 and 2. The sensor assembly 1000 may also includeone or more batteries 1018, which may be removable or replaceable.Battery 1018 may be electrically coupled to an electrical contact 1028,which may be sized and shaped to electrically couple with an electricalcontact 1030 on the sensor electronics module 1006, as further explainedbelow.

The base 1002 may include contacts 1008, which may be part of a contactsubassembly 1010. The contacts 1008 may be configured to electricallyand mechanically contact respective contacts (not shown) on the sensorelectronics module, e.g., to enable signal transfer or power transfer.The contact subassembly 1010 may include a hinge 1012 that is configuredto allow the contact subassembly 1010 to pivot between a first position(for insertion) and a second position (for use) relative to the mountingunit 1004. The term “hinge” as used herein is a broad term and is usedin its ordinary sense, including, without limitation, to refer to any ofa variety of pivoting, articulating, and/or hinging mechanisms, such asan adhesive hinge, a sliding joint, and the like; the term hinge doesnot necessarily imply a fulcrum or fixed point about which thearticulation occurs. In some examples, the contacts 1008 may be formedfrom a conductive elastomeric material, such as a carbon filledelastomer, in electrical connection with the sensor 1016.

In some examples, the mounting unit 1004 may be provided with anadhesive pad 1014, disposed on the mounting unit's back surface. Theadhesive pad may include a releasable backing layer. The mounting unit1004 may be adhered to the skin of a host by pressing the base 1002 ofthe mounting unit and the adhesive pad 1014 onto the skin. Appropriateadhesive pads can be chosen and designed to stretch, elongate, conformto, and/or aerate the region (e.g., host's skin). Various configurationsand arrangements can provide water resistant, waterproof, and/orhermetically sealed properties associated with the mounting unit/sensorelectronics module embodiments described herein. Any of the examplesdiscussed herein may be sealed to avoid, for example, exposure to wateror excessive exposure to moisture.

FIG. 10B is an enlarged view of a portion of the sensor assembly of FIG.10A. The base 1002 may be configured to receive one or more batteries1018, which may for example be coin cell batteries (e.g. silver oxide,lithium, alkaline, zinc air, etc.). A sealed region 1020 may extend overthe batteries to isolate and secure the batteries 1018 in the base 1002.In various embodiments, the sealed region may be coupled to the baseusing mechanical connections (e.g. snap fit), adhesives, welded joints,or any combination thereof.

The base 1002 may include one or more protrusions 1024 (e.g., sealmember or seal feature) that extend upward to the sensor electronicsmodule 1006. Electrical connector 1026 may extend through the protrusion1024 and electrically connect via electrical contact 1028 with a secondelectrical contact 1030 on the sensor electronics module 1006. In someexamples, an end surface 1034 of the protrusion 1024 (e.g., sealingmember) may seal against an opposing surface on the sensor electronicsmodule to form a seal (e.g., face seal.) In some examples, an outer sidesurface 1036 of the protrusion 1024 may seal against a correspondingsurface (e.g., an inner surface on a cavity on sensor electronics module1006) to form a radial seal (e.g., an O-ring or lip seal against thesensor electronical module.)

In the example shown in FIGS. 10A and 10B, the protrusion 1024 andelectrical connector 1026 are laterally offset from the one or morebatteries (i.e., to the right of the battery in FIG. 10B), in which casethe electrical connector 1026 may be electrically coupled with thebattery via electrical connector 1032. In some alternative examples,such as the embodiment shown in FIG. 13A, the protrusions may extendupward from batteries, as shown, for example, in FIG. 11A.

The protrusions 1024 may form a seal with the sensor electronics module1006 when the sensor electronics module is assembled with the base 1002.For example, the protrusions may form a radial seal or face seal withthe sensor electronics module 1006. The protrusions may be overmolded toa base or over or around the electrical contact 1028. Alternatively, aseal component may be coupled to the protrusion (e.g., the protrusionitself may be integral with the base and a seal component may beovermolded to the base or otherwise coupled to or placed around theprotrusion.) The protrusions or seal may be formed of a material to forma water-tight seal, such as an elastomeric or conformable material(e.g., Silicone, TPE, Polypropylene, etc.)).

Each of the example bases shown in FIGS. 10A through 39C may include oneor more electrical contacts 1028, 1029 that may be configured to deliverbattery power to a sensor electronics module (e.g., sensor electronicsmodule 106 or sensor electronics module 1006, not shown in FIGS.11A-39C). While some of the examples are shown with two batteries, otherexamples may include a single battery, or more than two batteries (e.g.,three, four, or more batteries.) In various examples, the batteries mayall be the same, or the batteries may be sized differently, or may havedifference electrical or electrochemical properties to provide desiredperformance characteristics (e.g., current capacity or battery life.) Inexamples with two or more batteries, the batteries may be arranged inseries or parallel, but preferably in series, so that one contact 1028is positive and the other contact 1029 is negative (or vice-versa) tothereby form a closed circuit when coupled with the sensor electronicsmodule. The base may also include electrical contacts 1008, 1010, whichmay be configured to interface with the sensor electronics module tooperatively couple one or more sensor system components (e.g.,potentiostat 202 shown in FIG. 2) to supply power to generate a sensorsignal (e.g., to apply a bias to via sensor 1016 to generate a signalindicative of an analyte concentration level). In some examples, acover, film, flex circuit substrate, potting material (e.g., epoxy), orother component may be provided and configured to extend over thebatteries and seal with the base. A sealed interface may be createdusing one or more of a sealing member (e.g. O-ring or elastomer),ultrasonic welding, laser, radiofrequency (RF), or heat welding. Asensor electronics sealing member may also be provided between thesensor electronics module 1006 and the base. In any of the examplesshown in FIGS. 10A-39C, the batteries may be coupled to a sensorelectronics package via conductive elastomeric contacts (e.g. pucks),springs, tabs, posts, pogo pins, flat conductive pads or traces, or anyother suitable conductive materials and/or structures, which may invarious configurations be affixed to the base, or to a sensorelectronics module. Any of the structural elements shown in FIGS.10A-39C may be combined with an example shown in another of the FIGS.10A-39C, and many of the examples may have similar or identicalcomponents, as shown in the drawings.

A battery seal may be provided between the sensor electronics module andthe batteries or battery contacts, for example to avoid contact betweenthe batteries and the outside environment (e.g., water during swimmingor bathing), which may corrode, deplete, or damage the batteries orelectronic components. The battery seal may, for example, be a faceseal, radial seal (e.g., O-ring), or an irregular seal. The seal may,for example, include an overmolded component such as an overmoldedgasket, an overmolded elastomeric feature that may be coupled to orassembled with the base or sensor electronics module, or otherovermolded or assembled seal components or features. The seal or sealsmay create one continuous seal around the perimeter of both batteries(e.g., see FIGS. 12A and 15A, 16A, 18A, and 19A), or may create a sealaround each battery individually (e.g., see FIGS. 11A, 13A, 14A, and23A-39C). In various configurations, the batteries 1018 may be assembledinto the base through the bottom of the base (e.g., see FIGS. 11A and11B, 13A-16B, 20A-25B, 28A-34 and 38A-39C), or through the top of thebase (e.g., see FIGS. 12A-12B, 17A-19B, 26A-37B and 35A-37D).

Any of the examples shown in FIGS. 11A through 39C may be coupled to anadhesive component such as adhesive pad 1014 shown in FIGS. 10A,23A-23C, 28A-28C, 30A-30B, 32, 34, 36 and/or 38A-38B, or alternativelyor additionally may include adhesive on the bottom surface 1052 of thebase, to couple the base to a host.

FIG. 11A is a perspective top view of an example sensor base 1102 thathas two protruding seal members 1124, 1125, which may be offset frombatteries 1018. FIG. 11A shows electrical contacts 1128, 1129 asconductive elastomeric puck style contacts that may press againstcorresponding contacts (not shown) on the sensor electronics moduleswhen the sensor electronics module is assembled with the base 1102.Battery power may be supplied to the sensor electronics module viaelectrical contacts 1128, 1129. The seal members 1124, 1125 may beconfigured to seal against a sensor electronics module (not shown) sothat electrical contacts 1128, 1129 may be sealed from exposure topotential environmental elements, such as water. The seal members 1124,1125, may, for example be overmolded elastomeric seal (e.g., overmoldedonto the base.) The seal members 1124 may form a face seal when pressedagainst sensor electronics module. In an example, the outer sidesurfaces 1130, 1131 of the sensor electronics module may seal againstone or more inner surfaces of corresponding cavities in the sensorelectronics module. Alternatively, or additionally, end surfaces 1132,1133 may form a seal against opposing surfaces on the sensor electronicsmodule.

FIG. 11B is a perspective bottom view of the base 1102. The batteries1018 may be sealed in the base. In some examples, the analyte sensor1016 (not shown in FIG. 11B) may be delivered through the bottom surface1104 of the base 1102 and into a host, e.g., through a hole (not shownin FIG. 11B) in the sealed region 1020 (e.g., cover.) The analyte sensor2016 may, for example, be delivered via a mechanical or electricaldelivery system (e.g., applicator, not shown), which may, for example,be configured to insert a needle/sensor assembly into a host andwithdraw the needle to leave the sensor in the host for sensing ananalyte (e.g., glucose) concentration. Example sensor delivery systemsare shown and described in U.S. Pat. No. 7,949,381, U.S. patentapplication Ser. No. 15/387,088 (published as US20170188910A1), and U.S.patent application Ser. No. 15/298,721 (published as US20170112534A1)which are incorporated by reference. Any of the examples shown in FIGS.11A-39C may be similarly configured to receive a sensor 1016 and sensordelivery system.

The base 1102 and the bases shown in FIGS. 12A-39C may include amounting unit 1004, electrical contacts 1008, 1010, and a sealed region1020, as described in reference to at least FIGS. 10A and 10B.

FIGS. 12A and 12B illustrate an example base 1202 in which batteries maybe loaded from a top side as opposed to a bottom side as shown in FIG.11B. A seal member 1224 may extend around both batteries 1218, 1219 andoptionally also around battery contacts 1228, 1229. Battery contacts1228, 1229 may be separate parts, or may be a portion of a battery. Theseal member 1224 may be overmolded to the base or assembled with thebase and placed around battery contacts 1228, 1229, or around thebattery contacts 1228, 1229 and the batteries 1018. An outer surface1230 of the seal member 1224 may be configured to seal against anopposing internal surface (e.g., inner surface of a cavity) on thesensor electronics module (e.g., sealed against inner surface 1952 onsensor electronics module 1904 in FIG. 19B). Additionally, oralternatively, an inner surface 1231 of the seal member 1224 may beconfigured to seal against an opposing surface on the sensor electronicsmodule. As shown in FIG. 12B, the batteries 1218, 1219 may beelectrically coupled via connector 1232. A sensor (e.g., sensor 104 orsensor 1016) may be delivered via a passageway in the base such as thehole 1240 shown in FIG. 12B.

FIGS. 13A and 13B illustrate an example base 1302 that includes sealmembers 1324, 1325 having side surface 1330, 1331 that may form a faceseal with corresponding surfaces on the sensor electronics module (e.g.seal against inner surfaces of a cavity on sensor electronics module) toseal battery electrical contacts 1328 1329 against exposure to water ormoisture. Additionally. or alternatively, the end surfaces 1332, 1333may form a seal against the sensor electronics module.

FIG. 13B shows a film 1310 (or alternatively flex circuit substrate)that may be laser or heat bonded (e.g., glued or welded) to the mountingunit 1304 to seal the batteries in the mounting unit 1304. For example,a sealed path 1312 may be laser bonded or heat bonded around thebatteries to create an isolated region around the batteries. A sensor(e.g., sensor 104 or sensor 1016) may be delivered via a passageway inthe base such as the hole 1340 shown in FIG. 13B.

FIGS. 14A and 14B illustrate an example base 1402 and sensor electronicsmodule 1450. The sensor electronics module may include one or moreprotrusions 1452 (e.g., second protrusion is behind base and thus notshown) that include one or more electrical contacts 1454 that isconfigured to electrically couple with electrical contacts 1428, 1429 onthe base 1402. Protrusion 1452 may be configured to fit intocorresponding recesses 1434, 1435 in seal members 1424, 1425 so that oneor more outer surfaces 1456 on the protrusion form a radial seal withseal members.

The seal members 1424, 1425 may also optionally have end surfaces 1432,1433 that may be sized and shaped to form seal against an opposingsurface 1458 on the sensor electronics module to further seal batteryelectrical contacts 1428 1429 against exposure to water or moisture.

FIG. 14B shows a film 1410 (or alternatively flex circuit substrate)that may be laser or heat bonded to the mounting unit 1404 to seal thebatteries in the mounting unit 1404. For example, a sealed weld path1412 may be laser bonded or heat bonded around the batteries to createan isolated region around the batteries.

FIGS. 15A and 15B illustrate an example base 1502 having a seal member1524 that may extend around one or more battery contacts 1528, 1529. Anouter surface 1530, inner surface 1531, or both, may be configured toseal against corresponding opposing surfaces on a sensor electronicsmodule (not shown in FIG. 15A, 15B) to form a seal around both batterycontacts. The seal member 1524 may, for example, be an overmoldedelastomeric gasket.

FIGS. 16A and 16B illustrate an example base 1602 having a seal member1624 that may extend around one or more battery contacts 1628, 1629. Anouter surface 1630 of the seal member may include one or more ribs 1631that may form a radial seal (e.g., similar to an O-ring) with an innersurface 1652 of a cavity 1654 formed by the sensor electronics module1650. The seal member 1624 may, for example, be a molded elastomericseal placed over the battery contacts 1628, 1629. In another example,the seal member 1624 may be overmolded onto the base.

FIGS. 17A and 17B illustrate an example base 1702 that includes a radialseal (e.g., O-ring seal) that extends around a bottom component 1704 ofthe base. The radial seal 1724 and a top component 1706 (which may be aportion of a sensor electronics module) may be configured to form afluid-tight seal to avoid exposure to water or moisture.

FIGS. 18A and 18B illustrate an example base 1802 that includes a radialseal that extends around a bottom component 1804 of the base. The radialseal 1824 and a portion 1806 of a sensor electronics module may beconfigured to form a fluid-tight seal to avoid exposure to water ormoisture. The radial seal 1824 may, for example, be or include anovermolded elastomeric feature (e.g., overmolded onto the base so thatit extends around inserted batteries or battery contacts).

FIGS. 19A and 19B illustrate an example base 1902 that includes a sealmember 1924 that extends around both batteries 1918, 1919. The sealmember 1924 may be overmolded to the base, and sized and shaped toextend around batteries 1918, 1919 (or around the battery contacts (notshown) and the batteries). An outer surface 1930 of the seal member 1924may include a ring feature 1931 that may be configured to seal againstan opposing internal surface 1954 in a cavity on sensor electronicsmodule 1950.

FIGS. 20A and 20B illustrate another example base 2002 that includes asingle seal member 2024 that may include a cavity 2126 that may beconfigured to receive a protrusion 2052 extending from a bottom side2054 of a sensor electronics module 2050. The seal member 2024 may beconfigured to seal against an outer surface 2058 of a protrusion. Insome examples, the seal member 2024 may form a face seal with theprotrusion 2052, or may form a radial seal (e.g., via an internal rib(not shown) in the cavity 2026 on the seal member). The protrusion 2052may include one or more electrical contacts 2056 (e.g., a secondcontact, not shown, may be on the other side of the protrusion tocomplete a circuit, see, e.g., FIG. 21B.) The electrical contacts 2056may electrically couple with corresponding contacts (not shown) on aninside surface of the seal member 2024 (e.g., on the walls inside thecavity 2026 on the seal member 2024 that receives the protrusion.)

FIGS. 21A and 21B illustrate another example base 2102 that includes asingle seal member 2124 that may include a cavity 2126 that may beconfigured to receive a protrusion 2152 extending from a bottom side2154 of a sensor electronics module 2150. The seal member 2124 may beconfigured to seal against an outer surface 2158 of a protrusion. Invarious examples, the seal member 2124 may form a face seal with theprotrusion 2152, or may form a radial seal (e.g., via an internal rib(not shown) in the cavity 2126 on the seal member). The protrusion 2152may include one or more electrical contacts 2156, 2160. The electricalcontacts 2156, 2160 may electrically couple with corresponding contacts(not shown) on an inside surface of the seal member 2124 (e.g., on thewalls inside the cavity 2126 on the seal member 2124 that receives theprotrusion.)

FIGS. 22A and 22B illustrate another example base 2202 that is similarto the example 1102 shown in FIG. 11A, but in which seal members 2224,2225 are situated in a front portion 2204 of the base 2202.

Toe-In Embodiments

Several embodiments utilizing a protrusion or “toe” on a sensorelectronics module to secure the sensor electronics module to a base aredescribed in connection with FIGS. 23A-29C below.

While not shown in FIGS. 23A-29C, bases 2302-2902 can comprise ananalyte sensor (e.g., analyte sensor 104 of FIG. 1, analyte sensor 212of FIG. 2, analyte sensor 1016 of FIG. 10A) configured to generate asensor signal indicative of an analyte (e.g., glucose) concentration ofa host, while sensor electronics modules 2350-2950 can include sensorelectronics (e.g., sensor electronics 106 of FIGS. 1 and/or 2) asdescribed herein and may include at least a wireless transceiverconfigured to transmit a wireless signal based at least in part on thesensor signal generated by the analyte sensor.

In some embodiments, an analyte sensor base assembly may include base2302-2902 configured to attach to a skin of a host and one or more ofthe analyte sensor as described above and configured to generate asensor signal indicative of an analyte concentration level of the host,at least one battery at least as will be described below, at least onesensor contact 2308-2908 and/or 2310-2910, at least one battery contact2328-2938 and/or 2329-2929, a sealing member 2324-2924 configured toprovide a seal around at least the at least one battery contact2328-2938 and/or 2329-2929, and/or any other features associated withand/or configured to couple with base 2302-2902 at least as describedbelow.

FIG. 23A is a perspective view of an example base 2302 and a sensorelectronics module 2350 configured to be secured to base 2302, accordingto some embodiments. FIG. 23B is a perspective view of sensorelectronics module 2350 secured to base 2350 of FIG. 23A. FIG. 23C is aplan view of sensor electronics module 2350 secured to base 2302 of FIG.23A. Discussion follows with respect to FIGS. 23A-23C.

As shown in the figures, analyte sensor system 2300 comprises base 2302and sensor electronics module 2350. Base 2302 can be configured toattach to the skin of the host, for example, utilizing an adhesive pad2314, which can be disposed on a back surface of base 2302. In someembodiments, adhesive pad 2314 can include a releasable backing layer.Base 2302 can be adhered to the skin of the host by pressing base 2302and adhesive pad 2314 onto the skin. Appropriate adhesive pads can bechosen and designed to stretch, elongate, conform to, and/or aerate thehost's skin. Various configurations and arrangements can provide waterresistant, waterproof, and/or hermetically sealed properties associatedwith the base/sensor electronics module embodiments described herein.

In some embodiments, base 2302 can be configured to physically and/ormechanically couple with sensor electronics module 2350 utilizing one ormore retaining features. For example, base 2302 can have a raisedperimeter 2304 configured to at least partially surround sensorelectronics module 2350 as sensor electronics module 2350 is physicallyand/or mechanically coupled to base 2302, thereby guiding sensorelectronics module 2350 into position during such physical and/ormechanical coupling.

To accomplish, affect and/or support such physical and/or mechanicalcoupling, base 2302 can further include a first retaining member 2342and a second retaining member 2344, while sensor electronics module 2350can further include a securement feature 2352 configured to mate withfirst retaining member 2342 and a retention feature 2356 configured tomate with second retaining member 2344.

First retaining member 2342 of base 2302 can comprise a recess, a ledge,a hook, a slit, or any other type of suitable retaining member. Firstretaining member 2342 can be disposed, for example, at a first end ofbase 2302. Second retaining member 2344 of base 2302 can comprise asnap, a hook, a button or any other suitable retaining member. Secondretaining member 2344 can be disposed, for example, at a second end ofbase 2302 opposite the first end.

Securement feature 2352 of sensor electronics module 2350 can comprise aprotrusion, a toe or any other type of suitable retention featureconfigured to mate with and be substantially immobilized by firstretaining member 2342 of base 2302. Retention feature 2356 of sensorelectronics module 2350 can comprise a recess, a ledge, a hook, a slit,or any other type of suitable retention feature configured to mate with,snap into and/or otherwise be substantially immobilized by secondretaining member 2344 of base 2302.

For example, to secure sensor electronics module 2350 to base 2302,securement feature 2352 of sensor electronics module 2350 can beinserted into first retaining member 2342 of base 2302 such that sensorelectronics module 2350 is disposed at an elevated angle with respect tobase 2302, as shown in FIG. 23A. Sensor electronics module 2350 can thenbe pivoted toward base 2302, substantially about mated first retainingmember 2342 and first retention feature 2352, until retention feature2356 and second retaining member 2344 mate with one another (e.g., snaptogether into a retaining orientation), thereby securing sensorelectronics module 2350 to base 2302, as shown in FIGS. 23B-23C.

In some embodiments, second retaining member 2344 is an integral part ofbase 2302 and is not configured to be separable from base 2302. In suchembodiments, second retaining member 2344 can be configured to releaseretention feature 2356 by, for example, applying enough force to secondretaining member 2344 to sufficiently deflect and thereby decouple itfrom second retention feature 2356. However, in other embodiments,similar to that described in more detail below in connection with atleast FIGS. 24A-24D, second retaining member 2344 can be disposed on afrangible tab 2362 of base 2302 that is configured to separate from base2302, thereby decoupling second retaining member 2344 from retentionfeature 2356 and decoupling sensor electronics module 2350 from base2302.

While not shown in FIGS. 23A-23C, base 2302 can comprise at least abattery (e.g., battery 292 of FIG. 2) configured to power the analytesensor and/or sensor electronics module 2350, a first sensor contact(e.g., similar to contact 2408 of FIG. 24A) and a second sensor contact(e.g., similar to contact 2410 of FIG. 24A), each electrically coupledto a respective terminal of the analyte sensor, and a first batterycontact (e.g., similar to contact 2428 of FIG. 24A) and a second batterycontact (e.g., similar to contact 2429 of FIG. 24A), each electricallycoupled to a respective terminal of the battery.

While not shown in FIGS. 23A-23C, sensor electronics module 2350 cancomprise a plurality of contacts (e.g., similar to contacts 2554 of FIG.25A), which can include a first signal contact configured to makeelectrical contact with the first sensor contact, a second signalcontact configured to make electrical contact with the second sensorcontact, a first power contact configured to make electrical contactwith the first battery contact, a second power contact configured tomake electrical contact with the second battery contact (e.g., see FIGS.24A-29C). Such first and second power contacts can be configured toreceive power from the battery, while such first and second signalcontacts can be configured to receive the sensor signal from the analytesensor.

While not shown in FIGS. 23A-23C, analyte sensor assembly 2300 canfurther include a first sealing member (e.g., see FIGS. 24A-29C)configured to surround and seal each of the first and second sensorcontacts, the first and second battery contacts, the first and secondsignal contacts and the first and second power contacts within a firstcavity.

FIGS. 24A-27B illustrate several variations and/or embodiments ofanalyte sensor systems similar to that of FIGS. 23A-23C and aredescribed in more detail below. Where appropriate, sensor electronicsmodule 2350 and base 2302 of FIGS. 23A-23C can be considered to includesome or all of the features as described in connection with any of atleast FIGS. 24A-27B.

FIG. 24A is a perspective view of a base 2402 including a cover 2460having a frangible tab 2462, on which a retaining member 2444 isdisposed, according to some embodiments. FIG. 24B is a perspectivemagnified view of frangible tab 2462 and retaining member 2444 of FIG.24A shown retaining a sensor electronics module 2450 to base 2402. FIG.24C is a perspective view of cover 2460 of FIG. 24A. And FIG. 24D is aperspective bottom view of base 2402. Discussion follows with respect toFIGS. 24A-24D.

An analyte sensor system 2400 can comprise base 2402 and sensorelectronics module 2450. As illustrated in the figures, base 2402includes a cover 2460 configured to be attached to and/or disposed on abottom side of base 2402. Cover 2460 can comprise a plurality ofconductive traces 2466, which can be formed utilizing any suitableprocess, for example, laser direct structuring (LDS) of cover 2460 orovermolding of a conductive elastomer. Conductive traces 2466 may beutilized to ultimately route electrical signals from the analyte sensorto sensor electronics module 2450 and/or power from a battery 2418 tosensor electronics module 2450 and to the analyte sensor. Cover 2460 mayfurther include a recess 2468 configured to receive battery 2418. It iscontemplated that fabricating traces 2466 onto cover 2460 instead ofonto base 2402 may benefit manufacturability due to the small size ofbase 2402 and the manufacturing process of LDS traces.

Cover 2460 is further illustrated as having a frangible tab 2462 coupledto a main body of cover 2460 by a break line 2464. Frangible tab 2462 isconfigured to separate from cover 2460 along break line 2464 whenfrangible tab 2462 is sufficiently bent, flexed or otherwise deflectedfrom its resting position shown in FIG. 24C. Cover 2460 can be securedto the bottom surface of base 2402 utilizing any suitable method, forexample, snaps, adhesive, friction fittings, heat-staking, and/or laser,heat or ultra-sonic welding along weld line 2412. As shown in FIG. 24D,once secured to base 2402, cover 2460 may secure battery 2418 within acavity in the bottom surface of base 2402.

As shown in FIG. 24A, base 2402 includes a sealing member 2424. A firstsensor contact 2408 and a second sensor contact 2410 are disposed insealing member 2424 and each is electrically coupled to a respectiveterminal of the analyte sensor (not shown in FIGS. 24A-24D) in base 2402via at least some of conductive traces 2466 a on cover 2460, as shown inFIG. 24C. For example, when cover 2460 is properly secured to a bottomside of base 2402, a first portion of conductive traces 2466 a can beconfigured to contact first and second sensor contacts 2408, 2410, and asecond portion of conductive traces 2466 a (e.g., at the portionscomprising raised post-like features illustrated in FIG. 24C) can befurther configured to contact respective terminals or electrodes of theanalyte sensor.

A first battery contact 2428 and a second battery contact 2429 are alsodisposed in sealing member 2424 and each is electrically coupled to arespective terminal of battery 2418 via at least some of conductivetraces 2466 b on cover 2460, also as shown in FIG. 24C. For example,when cover 2460 is properly secured to base 2402, a first portion ofconductive traces 2466 b can be configured to contact first and secondbattery contacts 2428, 2429, and a second portion of conductive traces2466 b (e.g., at the portions abutting and/or contacting cavity 2468 forreceiving battery 2418 as illustrated in FIG. 24C) can be furtherconfigured to contact respective terminals or electrodes of battery2418. In some embodiments, when cover 2460 is properly secured to base2402, a current-limiting diode 2498 (see FIG. 24C) can be disposed inseries between and electrically connecting at least two portions ofconductive traces 2466 b and can be configured to limit an amount ofcurrent that can be drawn from battery 2418, thereby increasing a usefullife of battery 2418. Such a current-limiting diode 2498 can be disposedwithin a pocket 2499 in base 2402 (see FIG. 24D).

In some embodiments, as shown in at least FIG. 24A, first and secondsensor contacts 2408, 2410 can be disposed a predetermined distance fromfirst and second battery contacts 2428, 2429, which can substantiallyreduce signal interference compared to embodiments (see, e.g., FIGS.25A-25B) where first and second sensor contacts 2508, 2510 and first andsecond battery contacts 2528, 2529 are disposed immediately adjacent toone another. The predetermined distance may be a distance sufficient tosubstantially reduce signal interference (e.g. leakage current, ioniccontamination) from the sensor contacts and/or battery contacts. Thepredetermined distance may be determined by the resistance of the PCBboard material and/or the solder mask over the contacts. In someembodiments, the predetermined distance is at least 1 millimeter. Insome embodiments, the predetermined distance is at least 2 millimeters.In some embodiments, the predetermined distance is at least 3millimeters. In some embodiments, the predetermined distance is at least4 millimeters. In some embodiments, the predetermined distance is atleast 5 millimeters. In some embodiments, the predetermined distance isat least 10 millimeters. In some embodiments, the predetermined distanceis at least 15 millimeters. Contacts 2408, 2410, 2428, 2429 can compriseconductive elastomeric contacts (e.g. pucks), springs, tabs, posts, pogopins, flat conductive pads or traces, or any other suitable conductivematerials and/or structures.

While not shown in FIGS. 24A-24D, a facing (e.g., bottom) surface ofsensor electronics module 2450 further comprises a plurality ofcontacts, which can include a first signal contact configured to makeelectrical contact with first sensor contact 2408, a second signalcontact configured to make electrical contact with second sensor contact2410, a first power contact configured to make electrical-contact withfirst battery contact 2428, and a second power contact configured tomake electrical contact with second battery contact 2429. Accordingly,the first and second signal contacts on the bottom surface of sensorelectronics module 2450 are configured to receive the sensor signal fromthe analyte sensor, while the first and second power contacts areconfigured to receive power from battery 2418 when sensor electronicsmodule 2450 is properly secured to base 2402. Such contacts on sensorelectronics module 2450 can comprise conductive elastomeric contacts(e.g. pucks), springs, tabs, posts, pogo pins, flat conductive pads ortraces, or any other suitable conductive materials and/or structures.

When sensor electronics module 2450 is secured to base 2402, sealingmember 2424 is configured to press against the facing surface of sensorelectronics module 2450, thereby forming a first cavity 2420 betweenbase 2402 and sensor electronics module 2450. Accordingly, singlesealing member 2424 is configured to surround and create one continuousseal around each of first and second sensor contacts 2408, 2410, firstand second battery contacts 2428, 2429, the first and second signalcontacts and the first and second power contacts of sensor electronicsmodule 2450 within first cavity 2420. Sealing member 2424 can, forexample, be comprised of or include an overmolded component such as anovermolded gasket, an overmolded elastomeric feature, and/or anultra-violet curable silicone that may be coupled to or assembled withbase 2402.

In some embodiments, base 2402 can be configured to physically and/ormechanically couple with sensor electronics module 2450 utilizing one ormore retaining features. For example, base 2402 can have a raisedperimeter 2404 configured to at least partially surround sensorelectronics module 2450 as sensor electronics module 2450 is physicallyand/or mechanically coupled to base 2402, thereby guiding sensorelectronics module 2450 into position during such physical and/ormechanical coupling.

To accomplish, affect and/or support such physical and/or mechanicalcoupling, base 2402 can further include a first retaining member 2442and a second retaining member 2444, while sensor electronics module 2450can further include a first retention feature (not shown in FIGS.24A-24D but having similar structure, function and location assecurement feature 2352 of FIGS. 23A-23C) configured to mate with firstretaining member 2442 and a retention feature 2456 configured to matewith second retaining member 2444. First and second retaining members2442, 2444, the securement feature and retention feature 2456 can havesimilar or the same structure, function and locations as first andsecond retaining members 2342, 2344, securement feature 2352 andretention feature 2356 of FIGS. 23A-23C, respectively.

To secure sensor electronics module 2450 to base 2402, the firstretention feature (not shown in FIGS. 24A-24D) of sensor electronicsmodule 2450 can be inserted into first retaining member 2442 of base2402 such that sensor electronics module 2450 is disposed at an elevatedangle with respect to base 2402, similar to that shown in FIG. 23A.Sensor electronics module 2450 can then be pivoted toward base 2402,substantially about mated first retaining member 2442 and the firstretention feature, until retention feature 2456 and second retainingmember 2444 mate with one another, thereby securing sensor electronicsmodule 2450 to base 2402 in an orientation as shown in FIGS. 23B-23C and24B.

As illustrated in FIGS. 24A-24C, second retaining member 2444 of base2402 can be disposed on frangible tab 2462 of cover 2460. Frangible tab2462 is configured to separate from base 2402 along break line 2464.Accordingly, reusable sensor electronics module 2450 can be decoupledfrom disposable base 2402 by sufficiently bending, flexing or otherwisedeflecting frangible tab 2462 from its resting position to decouplesecond retaining member 2444 from second retention feature 2456.Reusable sensor electronics module 2450, comprising relatively moreexpensive components than disposable base 2302, can then be securedand/or installed into a new disposable base 2402 having a fresh analytesensor and charged battery 2418 in preparation for a subsequent sensorsession for the host. Such an arrangement, wherein sensor electronics(e.g., including a wireless transceiver) are disposed in a mechanicallyseparable enclosure or module from the analyte sensor and/or battery,can advantageously allow for replacement of inexpensive components ofanalyte sensor system 2400 (e.g., base 2402) and reuse of relativelymore expensive components of analyte sensor system 2400 (e.g., sensorelectronics module 2450).

FIG. 25A is an exploded perspective view of an example base 2502 and asensor electronics module 2550 configured to be secured within base2502, according to some embodiments. FIG. 25B is a plan view of base2502 of FIG. 25A. Discussion follows with respect to FIGS. 25A-25B.

An analyte sensor system 2500 can comprise base 2502 and sensorelectronics module 2550. As with base 2402 of FIGS. 24A-24D, base 2502is configured to receive a battery 2518 within a cavity in a bottomsurface of base 2502. Base 2502 can also include a cover 2560 configuredto be attached to and/or disposed on a bottom side of base 2502.However, unlike cover 2460 of FIGS. 24A-24D, cover 2560 may not cover asubstantial portion of the bottom surface of base 2502 but may insteadbe shaped and sized to secure battery 2518 within base 2502. Cover 2560can be secured to the bottom surface of base 2502 utilizing any suitablemethod, for example, snaps, adhesive, friction fittings, heat-staking,and/or laser, heat or ultra-sonic welding along weld line 2512.

As shown in FIG. 25B, base 2502 can comprise a plurality of conductivetraces 2566, which can be formed utilizing any suitable process, forexample, laser direct structuring (LDS) of base 2502 or overmolding of aconductive elastomer. Conductive traces 2566 may be utilized toultimately route electrical signals from the analyte sensor to sensorelectronics module 2550 and/or power from battery 2518 to sensorelectronics module 2550 and to the analyte sensor. It is contemplatedthat fabricating traces 2566 directly onto base 2502 may reduce partcount and overall sensor electronics module size and/or volume.

Base 2502 further includes a first sensor contact 2508 and a secondsensor contact 2510, each electrically coupled to a respective terminalof the analyte sensor in base 2502 via at least some of conductivetraces 2566. Base 2502 further includes a first battery contact 2528 anda second battery contact 2529, each electrically coupled to a respectiveterminal of battery 2518 via at least some other of conductive traces2566. As shown in the figures, contacts 2508, 2510, 2528, 2529 can bedisposed immediately adjacent to one another (e.g., disposed along astraight or curvilinear line) and may comprise conductive elastomericcontacts (e.g. pucks), springs, tabs, posts, pogo pins, flat conductivepads or traces, or any other suitable conductive materials and/orstructures.

Base 2502 further includes a sealing member 2524, which can extend over,and thereby seal, conductive traces 2566 from moisture ingress and whichalso surrounds and creates a single continuous seal around contacts2508, 2510, 2528, 2529 on base 2302. Sealing member 2524 can, forexample, include an overmolded component such as an overmolded gasket,an overmolded elastomeric feature, and/or an ultra-violet curablesilicone that may be coupled to or assembled with base 2502.

A facing (e.g., bottom) surface of sensor electronics module 2550further comprises a plurality of contacts 2544, which can include afirst signal contact configured to make electrical contact with firstsensor contact 2508, a second signal contact configured to makeelectrical contact with second sensor contact 2510, a first powercontact configured to make electrical contact with first battery contact2528, and a second power contact configured to make electrical contactwith second battery contact 2529. Accordingly, the first and secondsignal contacts on the bottom surface of sensor electronics module 2550are configured to receive the sensor signal from the analyte sensor,while the first and second power contacts are configured to receivepower from battery 2518 when sensor electronics module 2550 is properlysecured to base 2502. Such contacts 2554 on sensor electronics module2550 can comprise conductive elastomeric contacts (e.g. pucks), springs,tabs, posts, pogo pins, flat conductive pads or traces, or any othersuitable conductive materials and/or structures.

When sensor electronics module 2550 is secured to base 2502, sealingmember 2524 is configured to press against the facing surface of sensorelectronics module 2550, thereby forming a first cavity 2520 betweenbase 2502 and sensor electronics module 2550. Accordingly, when sensorelectronics module 2550 is secured to base 2502, sealing member 2524 isconfigured to surround and create a continuous seal around each of firstand second sensor contacts 2508, 2510, first and second battery contacts2528, 2529, the first and second signal contacts and the first andsecond power contacts of sensor electronics module 2550.

In some embodiments, base 2502 can be configured to physically and/ormechanically couple with sensor electronics module 2550 utilizing one ormore retaining features. For example, base 2502 can have a raisedperimeter 2504 configured to at least partially surround sensorelectronics module 2550 as sensor electronics module 2550 is physicallyand/or mechanically coupled to base 2502, thereby guiding sensorelectronics module 2550 into position during such physical and/ormechanical coupling.

To accomplish, affect and/or support such physical and/or mechanicalcoupling, base 2502 can further include a first retaining member 2542and a second retaining member (not shown in FIGS. 25A-25B but havingsimilar structure, function and location as second retaining member2344, 2444 of FIGS. 23A-24D), while sensor electronics module 2550 canfurther include a securement feature 2552 configured to mate with firstretaining member 2542 and a retention feature 2556 configured to matewith the second retaining member. First and second retaining members2542, securement feature 2552, and retention feature 2556 can havesimilar or the same structure, function and locations as first andsecond retaining members 2342, 2344, securement feature 2352 andretention feature 2356 of FIGS. 23A-23C, respectively, with theexception that securement feature 2552 may be wider than securementfeature 2352 of FIGS. 23A-23C.

While not shown in FIGS. 25A-25B, the second retaining member can bedisposed on base 2502, for example as described in connection with FIGS.23A-23C, rather than on a cover, for example as described in connectionwith FIGS. 24A-24D. In some embodiments, the second retaining member isan integral part of base 2502 and is not configured to be separable frombase 2302. In some other embodiments, base 2502 may comprise a frangibletab similar to that previously described in connection with at leastFIGS. 24A-24D and the second retaining member can be disposed on thefrangible tab. Sensor electronics module 2550 can be secured to anddecoupled from base 2502 substantially as previously described inconnection with at least FIGS. 23A-24D.

FIG. 26A is an exploded perspective view of an example base 2602 and asensor electronics module 2650 configured to be secured within base2602, according to some embodiments. FIG. 26B is a plan view of base2602 of FIG. 26A. Discussion follows with respect to FIGS. 26A-26B.

An analyte sensor system 2600 can comprise base 2602 and sensorelectronics module 2650. Base 2602 is configured to receive a battery2618 within a cavity in a top surface of base 2602. As shown in FIG.26B, base 2602 can comprise a plurality of conductive traces 2666, whichcan be formed utilizing any suitable process, for example, laser directstructuring (LDS) of base 2602 or overmolding of a conductive elastomer.Conductive traces 2666 may be utilized to ultimately route electricalsignals from the analyte sensor to sensor electronics module 2650 and/orpower from battery 2618 to sensor electronics module 2650 and/or to theanalyte sensor.

Base 2602 further includes a first sensor contact 2608 and a secondsensor contact 2610, each electrically coupled to a respective terminalof the analyte sensor in base 2602 via at least some of conductivetraces 2666. Base 2602 further includes a first battery contact 2628 anda second battery contact 2629, each electrically coupled to a respectiveterminal of battery 2618 via at least some other of conductive traces2666. In some embodiments, at least one terminal of battery 2618 can bea radial conductive connection comprising a conductive material disposedon a sidewall of a portion of base 2602 configured to hold battery 2618.Such a radial conductive terminal can be configured to both physicallysecure battery 2618 to base 2602 as well as provide electricalconnection from one battery terminal to one of battery contacts 2628,2629.

As shown in the figures and similar to embodiments illustrated by FIGS.25A-25B, contacts 2608, 2610, 2628, 2629 can be disposed immediatelyadjacent to one another (e.g., disposed along a straight or curvilinearline) and may comprise conductive elastomeric contacts (e.g. pucks),springs, tabs, posts, pogo pins, flat conductive pads or traces, or anyother suitable conductive materials and/or structures.

Base 2602 further includes a cover 2660 comprising a sealing member2624, which can extend over and thereby seal conductive traces 2666 andbattery 2618 and which also surrounds and creates a continuous sealaround each of contacts 2608, 2610, 2628, 2629 on base 2302. Cover 2660and/or sealing member 2624 can, for example, include an overmoldedcomponent such as an overmolded gasket, an overmolded elastomericfeature, and/or an ultra-violet curable silicone that may be coupled toa surface of base 2602 utilizing any suitable method, for exampleadhesive, heat-staking, and/or laser, heat or ultra-sonic welding alongweld line 2612. Because cover 2660 can also extend over a through-hole2640 of base 2602, cover 2660 can also comprise a second seal 2625surrounding through-hole 2640. Due to cover 2660 extending oversubstantially all or a significant majority of a top surface of base2602, cover 2660 may act as an insulating cover for all or at least someof the components of base 2602 disposed thereunder.

A facing (e.g., bottom) surface of sensor electronics module 2650further comprises a plurality of contacts 2654, which can include afirst signal contact configured to make electrical contact with firstsensor contact 2608, a second signal contact configured to makeelectrical contact with second sensor contact 2610, a first powercontact configured to make electrical contact with first battery contact2628, and a second power contact configured to make electrical contactwith second battery contact 2629. Accordingly, the first and secondsignal contacts on the bottom surface of sensor electronics module 2650are configured to receive the sensor signal from the analyte sensor,while the first and second power contacts are configured to receivepower from battery 2618 when sensor electronics module 2650 is properlysecured to base 2602. Such contacts on sensor electronics module 2650can comprise conductive elastomeric contacts (e.g. pucks), springs,tabs, posts, pogo pins, flat conductive pads or traces, or any othersuitable conductive materials and/or structures.

When sensor electronics module 2650 is secured to base 2602, portions ofsealing member 2624 on cover 2660 and around contacts 2608, 2610, 2628,2629 are configured to press against the facing surface of sensorelectronics module 2650, thereby forming a first cavity 2620 betweenbase 2602 and sensor electronics module 2650. Accordingly, when sensorelectronics module 2650 is secured to base 2602, sealing member 2624 isconfigured to surround and create a continuous seal around first andsecond sensor contacts 2608, 2610, first and second battery contacts2628, 2629, and the plurality of contacts 2654 (e.g., the first andsecond signal contacts and the first and second power contacts) ofsensor electronics module 2650.

In some embodiments, base 2602 can be configured to physically and/ormechanically couple with sensor electronics module 2650 utilizing one ormore retaining features. For example, base 2602 can have a raisedperimeter 2604 configured to at least partially surround sensorelectronics module 2650 as sensor electronics module 2650 is physicallyand/or mechanically coupled to base 2602, thereby guiding sensorelectronics module 2650 into position during such physical and/ormechanical coupling.

To accomplish, affect and/or support such physical and/or mechanicalcoupling, base 2602 can further include a first retaining member 2642and a second retaining member (not shown in FIGS. 26A-26B but havingsimilar structure, function and location as second retaining member 2344(FIG. 23A), 2444 (FIG. 24D), while sensor electronics module 2650 canfurther include a securement feature 2652 configured to mate with firstretaining member 2642 and a retention feature 2656 configured to matewith the second retaining member. First and second retaining members2642, securement feature 2652 and retention feature 2656 can havesimilar or the same structure, function and locations as first andsecond retaining members 2342, 2344, securement feature 2352, andretention feature 2356 of FIGS. 23A-23C, respectively, with theexception that securement feature 2652 may be wider than securementfeature 2352 of FIGS. 23A-23C, similar to securement feature 2552 ofFIGS. 25A-25B, but also having a substantially rounded front edge.

While not shown in FIGS. 26A-26B, the second retaining member can bedisposed on base 2602, for example as described in connection with FIGS.23A-23C and 25A-25B, rather than on a cover, for example as described inconnection with FIGS. 24A-24D. In some embodiments, the second retainingmember is an integral part of base 2602 and is not configured to beseparable from base 2302. In some other embodiments, base 2602 maycomprise a frangible tab similar to that previously described inconnection with at least FIGS. 24A-24D and the second retaining membercan be disposed on the frangible tab. Sensor electronics module 2650 canbe secured to and decoupled from base 2602 substantially as previouslydescribed in connection with at least FIGS. 23A-24D.

FIG. 27A is an exploded perspective view of an example base 2702 and asensor electronics module 2750 configured to be secured within base2702, according to some embodiments. FIG. 27B is a plan view of base2702 of FIG. 27A. Discussion follows with respect to FIGS. 27A-27B.

An analyte sensor system 2700 can comprise base 2702 and sensorelectronics module 2750. While several features are not shown in FIGS.27A-27B, base 2702 and sensor electronics module 2750 can comprisesubstantially the same features as previously described for base 2602and sensor electronics module 2650 in connection with FIGS. 26A-26B withthe following differences.

Securement feature 2752 of sensor electronics module 2750, configured tomate with first retaining member 2742 of base 2702, can comprise aprotrusion or “toe” similar to that previously described for firstretaining member 2342 of FIGS. 23A-23C. In addition, rather than firstsealing member 2724 covering a substantial portion of a top surface ofbase 2702, first sealing member 2724 may instead form a continuouscircumferential seal that extends around a battery 2718, disposed in acavity in a top surface of base 2702, and each of the contacts on base2302. A separate, second sealing member 2725 can surround a through-hole2740 in base 2702. Sealing members 2724, 2725 can, for example, includeovermolded components such as overmolded gaskets, overmolded elastomericfeatures, and/or ultra-violet curable silicone that may be coupled to asurface of base 2702 utilizing any suitable method. In addition, in someembodiments, power and signal contacts 2754 on an underside of sensorelectronics module 2750 may directly contact respective terminals onbattery 2718 and respective leads of the analyte sensor (not shown inFIGS. 27A-27B), rather than being connected via a plurality ofconductive traces at locations removed from such terminals and leads.

FIGS. 28A-29C illustrate several variations and/or embodiments ofanalyte sensor systems similar to that of at least FIGS. 23A-27B,however, providing electrical contacts on a first retention feature of asensor electronics module, and are described in more detail below.

FIG. 28A is a perspective view of an example base 2802 and a sensorelectronics module 2850 configured to be secured within base 2802,according to some embodiments. FIG. 28B is a perspective view of sensorelectronics module 2850 secured to base 2802 of FIG. 28A. FIG. 28C is aplan view of sensor electronics module 2850 secured to base 2802 of FIG.28A.

As shown in the figures, analyte sensor system 2800 comprises base 2802and sensor electronics module 2850. Base 2802 can be configured toattach to the skin of the host, for example, utilizing an adhesive pad2814, which can be disposed on a back surface of base 2802. Adhesive pad2814 can have substantially similar features and function as previouslydescribed for adhesive pad 2314 of FIGS. 23A-23C.

Base 2802 can be configured to physically and/or mechanically couplewith sensor electronics module 2850 utilizing one or more retainingfeatures. For example, base 2802 can have a raised perimeter 2804configured to at least partially surround sensor electronics module 2850as sensor electronics module 2850 is physically and/or mechanicallycoupled to base 2802, thereby guiding sensor electronics module 2850into position during such physical and/or mechanical coupling.

To accomplish, affect and/or support such physical and/or mechanicalcoupling, base 2802 can further include a first retaining member 2842and a second retaining member 2844, while sensor electronics module 2850can further include a securement feature 2852 configured to mate withfirst retaining member 2842 and a retention feature 2856 configured tomate with second retaining member 2844.

First retaining member 2842 of base 2802 can comprise a cap or hood andcan be disposed, for example, at a first end of base 2802. Secondretaining member 2844 of base 2802 can comprise a snap, a hook, a buttonor any other suitable retaining member. Second retaining member 2844 canbe disposed, for example, at a second end of base 2802 opposite thefirst end.

Securement feature 2852 of sensor electronics module 2850 can comprise aprotrusion, a toe or any other type of suitable retention featureconfigured to mate with and be substantially immobilized by firstretaining member 2842 of base 2802. Retention feature 2856 of sensorelectronics module 2850 can comprise a recess, a ledge, a hook, a slit,or any other type of suitable retention feature configured to mate with,snap into and/or otherwise be substantially immobilized by secondretaining member 2844 of base 2802.

Sensor electronics module 2850 can comprise a plurality of contacts2854, which can include first and second signal contacts and first andsecond power contacts, each disposed on first retention feature 2852.Such first and second power contacts can be configured to receive powerfrom a battery (not shown in FIGS. 28A-28B) disposed within base 2802,while such first and second signal contacts can be configured to receivethe sensor signal from the analyte sensor. Accordingly, securementfeature 2852 is configured to secure sensor electronics module 2850 tobase 2802 and also provide electrical connections therebetween,utilizing the same structure for both, disparate functions.

Sensor electronics module 2850 can further include a first sealingmember 2824 configured to surround and seal each of the first and secondsensor contacts and the first and second battery contacts within a firstcavity 2820 located within the cap or hood formed by first retainingmember 2842 of base 2802. For example, first sealing member 2824 can bea radial or slot seal disposed around a circumference of securementfeature 2852 and configured to press against an inner surface of the capor hood formed by first retaining member 2842 and/or of base 2802 whensensor electronics module 2850 is properly secured to base 2802.

While not shown in FIGS. 28A-28C, base 2802 further comprises aplurality of electrical contacts (e.g., see contacts 2908, 2910, 2928,2929 of FIGS. 29A-29C) disposed within the cap or hood formed by firstretaining member 2842 of base 2802, for example including first andsecond sensor contacts, each electrically coupled to a respectiveterminal of the analyte sensor, and first and second battery contacts,each electrically coupled to a respective terminal of the battery (e.g.,see battery 2918 of FIGS. 29A-29C). The first and second signal contactsand the first and second power contacts (e.g., together contacts 2954)of sensor electronics module 2850 are configured to electrically contactthe first and second sensor contacts and the first and second batterycontacts (e.g., see contacts 2908, 2910, 2928, 2929 of FIGS. 29A-29C) ofbase 2802, respectively, when sensor electronics module 2850 is properlysecured to base 2802.

To secure sensor electronics module 2850 to base 2802, securementfeature 2852 of sensor electronics module 2850 can be inserted intofirst retaining member 2842 of base 2802 such that sensor electronicsmodule 2850 is disposed at an elevated angle with respect to base 2802,as shown in FIG. 28A. Sensor electronics module 2850 can then be pivotedtoward base 2802, substantially about mated first retaining member 2842and securement feature 2852, until retention feature 2856 and secondretaining member 2844 mate with one another (e.g., snap together into aretaining orientation), thereby securing sensor electronics module 2850to base 2802, as shown in FIGS. 28B-28C. In some embodiments, a forcerequired to secure sensor electronics module 2850 to base 2802 and,thereby, seal contacts 2908, 2910, 2928, 2929 within first cavity 2820can be less than for some other toe-in concepts (see, e.g., FIGS.23A-27B) at least because first sealing member 2824 is disposed around acircumference of securement feature 2852, rather than on a portion ofbase 2802 or on a cover that is laterally spaced from securement feature2852.

In some embodiments, second retaining member 2844 is an integral part ofbase 2802 and is not configured to be separable from base 2802. In suchembodiments, second retaining member 2844 can be configured to releaseretention feature 2856 by, for example, applying enough force to secondretaining member 2844 to sufficiently deflect and thereby decouple itfrom second retention feature 2856. However, in other embodiments,similar to those previously described in connection with at least FIGS.23A-24D, second retaining member 2844 can be disposed on a frangible tab2862 of base 2802 that is configured to separate from base 2802, therebydecoupling second retaining member 2844 from retention feature 2856 andso decoupling sensor electronics module 2850 from base 2802.

FIGS. 29A-29C illustrate a variation and/or embodiment of an analytesensor system similar to that of FIGS. 28A-28C, which is described inmore detail below. FIG. 29A is an exploded perspective view of anexample base 2902 and a sensor electronics module 2950 configured to besecured within base 2902, according to some embodiments. FIG. 29B is aperspective view of portions of base 2902 of FIG. 29A. FIG. 29C is aperspective view of a bottom of base 2902 of FIG. 29A. Discussionfollows with respect to FIGS. 29A-29C.

An analyte sensor system 2900 can comprise base 2902 and sensorelectronics module 2950. Base 2902 is configured to receive a battery2918 within a cavity in a bottom surface of base 2902. Base 2902 canalso include a cover 2960 (shown as transparent for illustrativepurposes) configured to be attached to and/or disposed on a bottom sideof base 2902 and shaped and sized to secure battery 2918 within base2902. Cover 2960 can be secured to the bottom surface of base 2902utilizing any suitable method, for example, snaps, adhesive, frictionfittings, heat-staking, and/or laser, heat or ultra-sonic welding alongweld line 2912.

As shown in FIG. 29B, base 2902 can comprise a plurality of conductivetraces 2966, which can be formed utilizing any suitable process, forexample, laser direct structuring (LDS) of base 2902 or overmolding of aconductive elastomer. Conductive traces 2966 may be utilized toultimately route electrical signals from the analyte sensor to sensorelectronics module 2950 and/or power from battery 2918 to sensorelectronics module 2950 and/or to the analyte sensor. As illustrated inat least FIG. 29B, according to some embodiments, those of conductivetraces 2966 utilized to ultimately route electrical signals from theanalyte sensor to sensor electronics module 2950 can be disposed atleast a predetermined distance away from those of conductive traces 2966utilized to ultimately route power from battery 2918 to sensorelectronics module 2950 and/or to the analyte sensor. At least oneadvantage of such a disposition of conductive traces 2966 is reducedsignal interference between the electrical signal traces and the powertraces. Base 2902 further includes a first plurality of conductivecontacts 2937, each in electrical contact with a respective one ofconductive traces 2966. Conductive contacts 2937 can comprise conductiveelastomeric contacts (e.g. pucks), springs, tabs, posts, pogo pins, flatconductive pads or traces, or any other suitable conductive materialsand/or structures. A sealing member 2925 (shown as transparent forillustrative purposes in FIG. 29B) is disposed over conductive traces2966 and around at least a portion of conductive contacts 2937. Sealingmember 2925 can, for example, include an overmolded component such as anovermolded gasket, an overmolded elastomeric feature, and/or anultra-violet curable silicone that may be coupled to or assembled withbase 2902.

Base 2902 further includes a first retaining member 2942, which, similarto first retaining member 2842 of FIGS. 28A-28B, can comprise a cap orhood and can be disposed, for example, at a first end of base 2902.Furthermore, in some instances, first retaining member 2942 can be aseparate component apart from base 2902, as shown in FIG. 29A. As shownin FIG. 29B, first retaining member 2942 further comprises a secondplurality of conductive contacts 2938, each configured to electricallycontact a respective one of conductive contacts 2937 of base 2902 whenfirst retaining member 2942 is secured to base 2902, for example byadhesive, welding or any other suitable method. First retaining member2942 further comprises a second plurality of conductive traces 2967,which, like conductive traces 2966 of base 2902, can be formed utilizingany suitable process, for example, laser direct structuring (LDS) offirst retaining member 2942 or overmolding of a conductive elastomer.First retaining member 2942 further comprises a sensor contact 2908, asecond sensor contact 2910, a first battery contact 2928 and a secondbattery contact 2929, each electrically coupled to a respective one ofconductive contacts 2938 via a respective one of conductive traces 2967.As shown in the figures, contacts 2908, 2910, 2928, 2929 can be disposedimmediately adjacent to one another (e.g., disposed along a straight orcurvilinear line) and may comprise conductive elastomeric contacts (e.g.pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces,or any other suitable conductive materials and/or structures.

First retaining member 2942 further includes a sealing member 2924(e.g., disposed on an inner surface of first retaining member 2942),which can extend over and thereby seal conductive traces 2967, aroundeach of conductive contacts 2937, and which also surrounds and createsone continuous seal around contacts 2908, 2910, 2928, 2929. Sealingmember 2924 can, for example, be composed of or include an overmoldedcomponent such as an overmolded gasket, an overmolded elastomericfeature, and/or an ultra-violet curable silicone that may be coupled toor assembled with first retaining member 2942.

Sensor electronics module 2950 includes a securement feature 2952configured to mate with first retaining member 2942. Securement feature2952 comprises a plurality of contacts 2954, which can include a firstsignal contact configured to make electrical contact with first sensorcontact 2908, a second signal contact configured to make electricalcontact with second sensor contact 2910, a first power contactconfigured to make electrical contact with first battery contact 2928,and a second power contact configured to make electrical contact withsecond battery contact 2929. Accordingly, the first and second signalcontacts on securement feature 2952 of sensor electronics module 2950are configured to receive the sensor signal from the analyte sensor,while the first and second power contacts are configured to receivepower from battery 2918 when sensor electronics module 2950 is properlysecured to base 2902. Such contacts 2954 on securement feature 2952 ofsensor electronics module 2950 can comprise conductive elastomericcontacts (e.g. pucks), springs, tabs, posts, pogo pins, flat conductivepads or traces, or any other suitable conductive materials and/orstructures. It is contemplated that including signal contacts 2954 intosecurement feature 2952 can increase space efficiency of sensorelectronics module 2950 and minimize the overall height and/or area ofsensor electronics module 2950.

When sensor electronics module 2950 is secured to base 2902, sealingmember 2924 is configured to press against the facing surface ofsecurement feature 2952 of sensor electronics module 2950, therebyforming a first cavity 2920 between base 2902 (e.g., first retainingmember 2942) and sensor electronics module 2950 (e.g., first retentionfeature 2952). Accordingly, when sensor electronics module 2950 issecured to base 2902, sealing member 2924 is configured to surround andcreate a continuous seal around first and second sensor contacts 2908,2910, first and second battery contacts 2928, 2929, the first and secondsignal contacts and the first and second power contacts of sensorelectronics module 2950 (e.g., contacts 2854).

Base 2902 can be configured to physically and/or mechanically couplewith sensor electronics module 2950 utilizing one or more retainingfeatures. For example, base 2902 can have a raised perimeter 2904configured to at least partially surround sensor electronics module 2950as sensor electronics module 2950 is physically and/or mechanicallycoupled to base 2902, thereby guiding sensor electronics module 2950into position during such physical and/or mechanical coupling.

To accomplish, affect and/or support such physical and/or mechanicalcoupling, base 2902 can further include a second retaining member (notshown in FIGS. 29A-29C but having similar structure, function andlocation as second retaining member 2344, 2444 of FIGS. 23A-24D), whilesensor electronics module 2950 can further include a retention feature2956 configured to mate with the second retaining member. Secondretaining member 2942 and retention feature 2956 can have similar or thesame structure, function and locations as second retaining member 2344and retention feature 2356 of FIGS. 23A-23C, respectively.

While not shown in FIGS. 29A-29B, the second retaining member can bedisposed on base 2902, for example as described in connection with FIGS.23A-23C, rather than on a cover, for example as described in connectionwith FIGS. 24A-24D. In some embodiments, the second retaining member isan integral part of base 2902 and is not configured to be separable frombase 2902. In some other embodiments, base 2902 may comprise a frangibletab similar to that previously described in connection with at leastFIGS. 23A-24D and the second retaining member can be disposed on thefrangible tab. Sensor electronics module 2950 can be secured to anddecoupled from base 2902 substantially as previously described inconnection with at least FIGS. 23A-24D.

Example Over-the-Top Embodiments

Several “over the top” embodiments utilizing a sensor electronics moduleconfigured to be disposed over, surround and/or shroud an underlyingbase are described in connection with FIGS. 30A-37D below.

While not shown in FIGS. 30A-37D, bases 3002-3702 can comprise ananalyte sensor (e.g., analyte sensor 104 of FIG. 1, analyte sensor 212of FIG. 2, analyte sensor 1016 of FIG. 10A) configured to generate asensor signal indicative of an analyte (e.g., glucose) concentration ofa host, while sensor electronics modules 3050-3750 can include sensorelectronics (e.g., sensor electronics 106 of FIGS. 1 and/or 2) asdescribed herein and may include at least a wireless transceiverconfigured to transmit a wireless signal based at least in part on thesensor signal generated by the analyte sensor.

In some embodiments, an analyte sensor base assembly may include base3002-3702 configured to attach to a skin of a host and one or more ofthe analyte sensor as described above and configured to generate asensor signal indicative of an analyte concentration level of the host,at least one battery at least as will be described below, at least onesensor contact 3008-3708 and/or 3010-3710, at least one battery contact3028-3738 and/or 3029-3729, a sealing member 3024-3724 and/or 3325, 35253725 configured to provide a seal around at least the at least onebattery contact 3028-3738 and/or 3029-3729, and/or any other featuresassociated with and/or configured to couple with base 3002-3702 at leastas described below.

FIG. 30A is an exploded perspective view of an example base 3002 and asensor electronics module 3050 configured to be secured over or on base3002, according to some embodiments. FIG. 30B is a perspective assembledview of sensor electronics module 3050 secured to base 3002 of FIG. 30A.Discussion follows with respect to FIGS. 30A-30B below.

As shown in the figures, analyte sensor system 3000 comprises base 3002and sensor electronics module 3050. Base 3002 can be configured toattach to the skin of the host, for example, utilizing an adhesive pad3014, which can be disposed on a back surface of base 3002. Adhesive pad3014 can have substantially similar features and function as previouslydescribed for adhesive pad 2314 of FIGS. 23A-23C.

As shown in the figures, sensor electronics module 3050 can have araised perimeter 3004 configured to at least partially surround base3002 as sensor electronics module 3050 is physically and/or mechanicallycoupled to base 3002, thereby guiding sensor electronics module 3050into position during such physical and/or mechanical coupling.

Sensor electronics module 3050 can further include an aperture 3070. Insome embodiments, aperture 3070 can be shaped such that there are alimited number of orientations between sensor electronics module 3050and base 3002 that allow securing of one to the other. For example,aperture 3070 may have a shape that is symmetrical about at least oneaxis parallel to a top surface of sensor electronics module 3050 butthat is asymmetrical about at least one other axis parallel to the topsurface of sensor electronics module 3050. Such partially symmetricalshapes of aperture 3070 can make it easier for a host to secure sensorelectronics module 3050 to base 3002 in the proper orientation.

Base 3002 can have an outer perimeter or shape that compliments an innerperimeter or shape of raised perimeter 3004 of sensor electronics module3050. Base 3002 can further have a raised portion 3005 having an outerperimeter or shape that compliments an inner perimeter or shape ofaperture 3070. Accordingly, when sensor electronics module 3050 issecured over a top of base 3002, base 3002 is configured to fit securelywithin raised perimeter 3004 of sensor electronics module 3050 andraised portion 3005 is configured to fit securely within aperture 3070.In some embodiments, a battery may be located in a cavity (not shown inFIGS. 30A-30B) within raised portion 3005 of base 3002. In someembodiments, when properly secured, a top surface of raised portion 3005may sit substantially flush with a top surface of sensor electronicsmodule 3050, thereby providing tactile feedback that sensor electronicsmodule 3050 is properly secured to base 3002. However, the presentdisclosure is not so-limited and the top surface of raised portion 3005may sit at an elevated or reduced position compared to the top surfaceof sensor electronics module 3050. Accordingly, the use of aperture 3070in sensor electronics module 3050 and raised portion 3005 of base 3002allow analyte sensor system 3000 to have a significantly reducedthickness or depth compared to other analyte sensor systems.

Base 3002 can further comprise a first sensor contact 3008 and a secondsensor contact 3010, each electrically connected to a respectiveterminal of the analyte sensor, and a first battery contact 3028 and asecond battery contact 3029, each electrically connected to a respectiveterminal of the battery. FIG. 30A illustrates contacts 3008, 3010, 3028,3029 disposed on a sloped surface 3097 of raised portion 3005 of base3002. Advantages of disposing contacts 3008, 3010, 3028, 3029 disposedon sloped surface 3097 included but are not limited to space efficiencyand a lower profile of sensor electronics module 3050. However, thepresent disclosure is not so limited and contacts 3008, 3010, 3028, 3029can be disposed on any suitable surface of base 3002. Base 3002 canfurther comprise a first sealing member 3024 configured to surround andseal each of contacts 3008, 3010, 3028, 3029 within a first cavity 3020formed between facing surfaces of base 3002 and sensor electronicsmodule 3050 and first sealing member 3024. Sealing member 3024 can, forexample, include an overmolded component such as an overmolded gasket,an overmolded elastomeric feature, and/or an ultra-violet curablesilicone.

Sensor electronics module 3050 can comprise a plurality of contacts3054, disposed on an inner surface facing base 3002, which can include afirst signal contact configured to make electrical contact with firstsensor contact 3008, a second signal contact configured to makeelectrical contact with second sensor contact 3010, a first powercontact configured to make electrical contact with first battery contact3028, and a second power contact configured to make electrical contactwith second battery contact 3029. Such first and second power contactscan be configured to receive power from the battery, while such firstand second signal contacts can be configured to receive the sensorsignal from the analyte sensor. In some alternative embodiments, firstsealing member 3024 can alternatively be disposed on the same surface ofsensor electronics module 3050 as contacts 3054, facing base 3002, toform first cavity 3020.

Sensor electronics module 3050 can be secured to base 3002 by pressingsensor electronics module 3050 against base 3002 in a directionsubstantially perpendicular to a bottom surface of base 3002 until oneor more retention features (not shown in FIGS. 30A-30B) of sensorelectronics module 3050 couple with one or more corresponding retainingmembers (not shown in FIGS. 30A-30B) of base 3002. In some embodiments,the retaining members of base 3002 may be the same members or featuresutilized to secure base 3002 to an applicator (not shown) for initialdeployment to the skin of the host. Sensor electronics module 3050 canbe decoupled from base 3002 by pulling sensor electronics module 3050perpendicularly away from base 3002 while pushing against raised portion3005 of base 3002 with sufficient force to cause decoupling.

An embodiment similar to that described in connection with FIGS. 30A-30Cis shown in FIGS. 31A-31C and described below. FIG. 31A is an explodedperspective view of an example base 3102 and a sensor electronics module3150 configured to be secured over or on base 3102, according to someembodiments. FIG. 31B is a perspective view of a battery 3118 disposedon a cover 3160 of base 3102 of FIG. 31A. FIG. 31C is a perspectivebottom view of base 3102 and sensor electronics module 3150 of FIG. 31A.Discussion follows with respect to FIGS. 31A-31C below.

As shown in the figures, analyte sensor system 3100 comprises base 3102and sensor electronics module 3150. As shown in the figures, sensorelectronics module 3150 can have a raised perimeter 3104 configured toat least partially surround base 3102 as sensor electronics module 3150is physically and/or mechanically coupled to base 3102, thereby guidingsensor electronics module 3150 into position during such physical and/ormechanical coupling.

Sensor electronics module 3150 further includes an aperture 3170.Similar to aperture 3070 of FIGS. 30A-30C, aperture 3170 can be shapedsuch that there are a limited number of orientations between sensorelectronics module 3150 and base 3102 that allow them to be secured toone another, making it easier for a host to secure sensor electronicsmodule 3150 to base 3102 in the proper orientation.

Base 3102 can have an outer perimeter or shape that compliments an innerperimeter or shape of raised perimeter 3104 of sensor electronics module3150. Base 3102 can further have a raised portion 3105 having an outerperimeter or shape that compliments an inner perimeter or shape ofaperture 3170. Accordingly, when sensor electronics module 3150 issecured over a top of base 3102, base 3102 is configured to fit securelywithin raised perimeter 3104 of sensor electronics module 3150 andraised portion 3105 is configured to fit securely within aperture 3170.

As shown in FIG. 31A, a battery 3118 may be located in a cavity withinraised portion 3105 of base 3102. As previously described in connectionwith FIGS. 30A-30C, when properly secured, a top surface of raisedportion 3105 may sit substantially flush with, at an elevated positioncompared to, or at a lowered position compared to a top surface ofsensor electronics module 3150, thereby providing tactile feedback thatsensor electronics module 3150 is properly secured to base 3102.

Base 3102 is shown having a cover 3160 configured to be attached toand/or disposed on a bottom side of base 3102. Cover 3160 can comprise aplurality of conductive traces 3166, which can be formed utilizing anysuitable process, for example, laser direct structuring (LDS) of cover3160 or overmolding of a conductive elastomer. Conductive traces 3166may be utilized to ultimately route electrical signals from the analytesensor to sensor electronics module 3150 and/or power from battery 3118to sensor electronics module 3150 and to the analyte sensor. Cover 3160may be further configured to receive battery 3118. Cover 3160 can besecured to the bottom surface of base 3102 utilizing any suitablemethod, for example, snaps, adhesive, friction fittings, heat-staking,and/or laser, heat or ultra-sonic welding along weld line 3112. As shownin FIG. 31D, once secured to base 3102, cover 3160 may secure battery3118 within a cavity in the bottom surface of base 3102.

As shown in FIGS. 31A-31B, a first sensor contact 3108 and a secondsensor contact 3110 are each electrically coupled to a respectiveterminal of the analyte sensor in base 3102 via at least some ofconductive traces 3166 on cover 3160. A first battery contact 3128 and asecond battery contact 3129 are also each electrically coupled to arespective terminal of battery 3118 via at least some other ofconductive traces 3166 on cover 3160. Contacts 3108, 3110, 3128, 3129can comprise conductive elastomeric contacts (e.g. pucks), springs,tabs, posts, pogo pins, flat conductive pads or traces, or any othersuitable conductive materials and/or structures.

Base 3102 further comprises a first sealing member 3124. When cover 3160is secured to base 3102, each of contacts 3108, 3110, 3128, 3129 canprotrude through first sealing member 3124.

As shown in FIG. 31C, a facing (e.g., bottom) surface of sensorelectronics module 3150 further comprises a plurality of contacts 3154,which can include a first signal contact configured to make electricalcontact with first sensor contact 3108, a second signal contactconfigured to make electrical contact with second sensor contact 3110, afirst power contact configured to make electrical contact with firstbattery contact 3128, and a second power contact configured to makeelectrical contact with second battery contact 3129. Accordingly, thefirst and second signal contacts on the bottom surface of sensorelectronics module 3150 are configured to receive the sensor signal fromthe analyte sensor, while the first and second power contacts areconfigured to receive power from battery 3118 when sensor electronicsmodule 3150 is properly secured to base 3102. Such contacts on sensorelectronics module 3150 can comprise conductive elastomeric contacts(e.g. pucks), springs, tabs, posts, pogo pins, flat conductive pads ortraces, or any other suitable conductive materials and/or structures.

When sensor electronics module 3150 is secured to base 3102, sealingmember 3124 is configured to press against the facing surface of sensorelectronics module 3150, thereby forming a first cavity 3120 betweenbase 3102 and sensor electronics module 3150. Accordingly, sealingmember 3124 is configured to surround and create a continuous sealaround first and second sensor contacts 3108, 3110, first and secondbattery contacts 3128, 3129, the first and second signal contacts andthe first and second power contacts of sensor electronics module 3150within first cavity 3120. Sealing member 3124 can, for example, includean overmolded component such as an overmolded gasket, an overmoldedelastomeric feature, and/or an ultra-violet curable silicone that may becoupled to or assembled with base 3102.

Sensor electronics module 3150 can be secured to and decoupled from base3102 in similar fashions to that previously described in connection withFIGS. 30A-30C.

FIG. 32 is a perspective view of an example base 3202 and a sensorelectronics module 3250 configured to be secured over or on base 3202,according to some embodiments. Analyte sensor system 3200 comprises base3202 and sensor electronics module 3250.

Base 3202 can be configured to attach to the skin of the host, forexample, utilizing an adhesive pad 3214, which can be disposed on a backsurface of base 3202. Adhesive pad 3214 can have substantially similarfeatures and function as previously described for adhesive pad 2314 ofFIGS. 23A-23C.

Sensor electronics module 3250 is illustrated as having a raisedperimeter 3204 configured to at least partially surround base 3202 assensor electronics module 3250 is physically and/or mechanically coupledto base 3202, thereby guiding sensor electronics module 3250 intoposition during such physical and/or mechanical coupling.

Sensor electronics module 3250 can further include a protrusion 3252extending away from an underside of sensor electronics module 3250 andconfigured to mate within a corresponding recess 3242 in a top surfaceof base 3204 when sensor electronics module 3250 is properly orientedand secured to base 3202. Utilizing protrusion 3252 and recess 3242 canallow the host to properly orient and align sensor electronics module3250 with respect to base 3202 without direct line of sight of thealigning/securing process.

When sensor electronics module 3250 is secured over a top of base 3202,base 3202 is configured to fit securely within raised perimeter 3204 ofsensor electronics module 3250 and protrusion 3252 is configured to fitsecurely within recess 3242.

Further aspects of analyte sensor system 3200 are discussed inconnection with a similar embodiment as shown in FIGS. 33A-33C below.Accordingly, analyte sensor system 3200 can be considered to havesimilar or the same features as those described for analyte sensorsystem 3300 of FIGS. 33A-33D.

FIG. 33A is an exploded perspective view of an example base 3302 and asensor electronics module 3350 configured to be secured over or on base3302, according to some embodiments. FIG. 33B is a perspective view of abattery 3318 disposed on a cover 3360 of base 3302 of FIG. 33A. FIG. 33Cis an exploded perspective bottom view of cover 3360 and base 3302 ofFIG. 33A. And FIG. 33D is a perspective bottom view of cover 3360secured to base 3302 of FIG. 33A. Discussion follows with respect toFIGS. 33A-33D below.

As shown in the figures, analyte sensor system 3300 comprises base 3302and sensor electronics module 3350. Sensor electronics module 3350 canhave a raised perimeter 3304 configured to at least partially surroundbase 3302 as sensor electronics module 3350 is physically and/ormechanically coupled to base 3302, thereby guiding sensor electronicsmodule 3350 into position during such physical and/or mechanicalcoupling.

Sensor electronics module 3350 further includes a protrusion 3352 andbase 3202 further includes a recess 3342, similar to and havingsubstantially the same functionality as protrusion 3252 and recess 3242of FIG. 32, respectively.

In some embodiments, base 3302 can have an outer perimeter or shape thatcompliments an inner perimeter or shape of raised perimeter 3304 ofsensor electronics module 3350. However, the present disclosure is notso-limited and base 3302 can have any outer perimeter or shape that willfit securely within raised perimeter 3304 of sensor electronics module3350.

Base 3302 is shown having a cover 3360 configured to be attached toand/or disposed on a bottom side of base 3302. Cover 3360 can comprise aplurality of conductive traces 3366, which can be formed utilizing anysuitable process, for example, laser direct structuring (LDS) of cover3360 or overmolding of a conductive elastomer. Conductive traces 3366may be utilized to ultimately route electrical signals from the analytesensor to sensor electronics module 3350 and/or power from battery 3318to sensor electronics module 3350 and/or to the analyte sensor. Cover3360 can be secured to the bottom surface of base 3302 utilizing anysuitable method, for example, snaps, adhesive, friction fittings,heat-staking, and/or laser, heat or ultra-sonic welding along weld line3312. Once secured to base 3302, cover 3360 may secure battery 3318within a cavity in the bottom surface of base 3302.

As shown in FIGS. 33A-33B, a first sensor contact 3308 and a secondsensor contact 3310 are each electrically coupled to a respectiveterminal of the analyte sensor in base 3302 via at least some ofconductive traces 3366 on cover 3360. A first battery contact 3328 and asecond battery contact 3329 are also each electrically coupled to arespective terminal of battery 3318 via at least some other ofconductive traces 3366 on cover 3360. Contacts 3308, 3310, 3328, 3329can comprise conductive elastomeric contacts (e.g. pucks), springs,tabs, posts, pogo pins, flat conductive pads or traces, or any othersuitable conductive materials and/or structures.

Base 3302 further comprises a first sealing member 3324 and a secondsealing member 3325. When cover 3360 is secured to base 3302, contacts3308 and 3310 can protrude through first sealing member 3324 andcontacts 3328 and 3329 can protrude through second sealing member 3325.

As shown in FIG. 33A, a facing (e.g., bottom) surface of sensorelectronics module 3350 further comprises a plurality of contacts 3354,which can include a first signal contact configured to make electricalcontact with first sensor contact 3308, a second signal contactconfigured to make electrical contact with second sensor contact 3310, afirst power contact configured to make electrical contact with firstbattery contact 3328, and a second power contact configured to makeelectrical contact with second battery contact 3329. Accordingly, thefirst and second signal contacts on the bottom surface of sensorelectronics module 3350 are configured to receive the sensor signal fromthe analyte sensor, while the first and second power contacts areconfigured to receive power from battery 3318 when sensor electronicsmodule 3350 is properly secured to base 3302. Such contacts on sensorelectronics module 3350 can comprise conductive elastomeric contacts(e.g. pucks), springs, tabs, posts, pogo pins, flat conductive pads orcontacts, or any other suitable conductive materials.

When sensor electronics module 3350 is secured to base 3302, firstsealing member 3324 is configured to press against the facing surface ofsensor electronics module 3350, thereby forming a first cavity 3320 abetween base 3302 and sensor electronics module 3350, while secondsealing member 3325 is configured to press against the facing surface ofsensor electronics module 3350, thereby forming a second cavity 3320 bbetween base 3302 and sensor electronics module 3350. Accordingly, firstsealing member 3324 is configured to surround and create a continuousseal around first and second sensor contacts 3308, 3310 and the firstand second signal contacts of 3354 within first cavity 3320 a and thefirst and second power contacts of sensor electronics module 3350 withinfirst cavity 3320 a, while second sealing member 3325 is configured tosurround and create a continuous seal around first and second batterycontacts 3328, 3329 and the first and second power contacts of 3354within second cavity 3320 b. First and second sealing members 3324, 3325can, for example, include overmolded components such as overmoldedgaskets, overmolded elastomeric features, and/or ultra-violet curablesilicone that may be coupled to or assembled with base 3302.

Sensor electronics module 3350 can be secured to and decoupled from base3302 in similar fashions to that previously described in connection withFIGS. 30A-30C.

Omni-Directional Over-the-Top Embodiments

FIGS. 34-37D illustrate several embodiments of analyte sensor systems inwhich a sensor electronics module having a substantially circularprofile is configured to be omni-directionally secured to a base alsohaving a substantially circular profile.

FIG. 34 is an exploded perspective view of an example base 3402 and asensor electronics module 3450 configured to be secured over or on base3402, according to some embodiments.

Analyte sensor system 3400 comprises base 3402 and sensor electronicsmodule 3450. As illustrated, base 3402 and sensor electronics module3450 can each have a substantially circular profile, which allows foromni-directional alignment of one with respect to the other.

Base 3402 can be configured to attach to the skin of the host, forexample, utilizing an adhesive pad 3414, which can be disposed on a backsurface of base 3402. Adhesive pad 3414 can have substantially similarfeatures and function as previously described for adhesive pad 2314 ofFIGS. 23A-23C.

Base 3402 can have a raised perimeter 3404 configured to at leastpartially surround sensor electronics module 3450 as sensor electronicsmodule 3450 is physically and/or mechanically coupled to base 3402,thereby guiding sensor electronics module 3450 into position during suchphysical and/or mechanical coupling. In some embodiments, raisedperimeter 2404 can have a substantially circular perimeter. Base 3402can further include an aperture 3470, which, in some embodiments, canhave a substantially circular shape.

Sensor electronics module 3450 can have a substantially circular outerperimeter or shape that compliments an inner perimeter or shape ofraised perimeter 3404 of base 3450. Sensor electronics module 3450 canfurther have a raised portion 3405 having a substantially circular outerperimeter or shape that compliments an inner perimeter or shape ofaperture 3470. Accordingly, when sensor electronics module 3450 issecured over a top of base 3402, sensor electronics module 3450 isconfigured to fit securely within raised perimeter 3404 of base 3402 andraised portion 3405 is configured to fit securely within aperture 3470.In some embodiments, when properly secured, a bottom surface of raisedportion 3405 may sit substantially flush with a bottom surface of base3402. However, the present disclosure is not so-limited and the bottomsurface of raised portion 3405 may sit at an elevated or reducedposition compared to the bottom surface of base 3402. Accordingly, atleast some of the substantially circular shape and/or perimeters ofsensor electronics module 3450, raised portion 3405, raised perimeter3404 of base 3402 and/or of aperture 3470 allow for omni-directionalmounting of sensor electronics module 3450 to base 3402. It iscontemplated that the omni-directional mounting can increase convenienceto the user when installing the sensor electronics module 3450 withoutfirst having to align it.

Base 3402 can further comprise a first sensor contact 3408 and a secondsensor contact (not shown in FIG. 34 but substantially similar to firstsensor contact 3408), each configured to be electrically connected to arespective terminal of the analyte sensor, and a first battery contact3428 and a second battery contact 3429, each configured to beelectrically connected to a respective terminal of a battery (not shownin FIG. 34) disposed within base 3402. Base 3402 can further comprise afirst sealing member (not shown in FIG. 34 but substantially similar tofirst sealing member 3524 of FIGS. 35A-35D) configured to surround andseal the first and second sensor contacts 3408 and the first and secondbattery contacts 3428 within a first cavity 3420 formed between facingsurfaces of base 3402 and sensor electronics module 3450 and the firstsealing member. The first sealing member can, for example, include anovermolded component such as an overmolded gasket, an overmoldedelastomeric feature, and/or an ultra-violet curable silicone.

Sensor electronics module 3450 can comprise a plurality ofconcentrically-circular contacts 3454 disposed on an inner surfacefacing base 3402. In some embodiments, contacts 3454 may each have asubstantially ring-like form and may each be annularly spaced apart fromone another. As shown, contacts 3454 may be centered about raisedportion 3405, which allows contacts 3454 to make electrical contact withrespective ones of the first and second sensor contacts 3408 and thefirst and second battery contacts 3428 of base 3402 when sensorelectronics module 3450 is mounted to base 3402. Due to the annular formof each of contacts 3454, it is contemplated that sensor electronicsmodule 3450 can be mounted onto base 3402 in any orientation. Eachcontact 3454 can be configured to make contact with one of sensorcontacts or battery contacts at any point along the respective contact3454. Contacts 3454 can be formed utilizing any suitable process, forexample, laser direct structuring (LDS) of base 3502 or overmolding of aconductive elastomer. Contacts 3454 can include a first signal contactconfigured to make electrical contact with first sensor contact 3408, asecond signal contact configured to make electrical contact with thesecond sensor contact (not shown in FIG. 34), a first power contactconfigured to make electrical contact with first battery contact 3428,and a second power contact configured to make electrical contact withthe second battery contact (not shown in FIG. 34). Such first and secondpower contacts can be configured to receive power from the battery,while such first and second signal contacts can be configured to receivethe sensor signal from the analyte sensor. In some alternativeembodiments, the first sealing member (not shown in FIG. 34) canalternatively be disposed on the same surface, or an adjacent surface,of sensor electronics module 3450 as contacts 3454, facing base 3402 toform first cavity 3420.

Sensor electronics module 3450 can be secured to base 3402 by pressingsensor electronics module 3450 against base 3402 in a directionsubstantially perpendicular to a bottom surface of base 3402 until oneor more retention features of sensor electronics module 3450 snap intoone or more corresponding retaining members of base 3402. In someembodiments, the retaining members of base 3402 may be the same membersor features utilized to secure base 3402 to an applicator (not shown)for initial deployment to the skin of the host. Sensor electronicsmodule 3450 can be decoupled from base 3402 by pulling sensorelectronics module 3450 perpendicularly away from base 3402 whileanchoring base 3402 with sufficient force to cause decoupling.

An embodiment similar to that described in connection with FIG. 34 isshown in FIGS. 35A-35D and described below. FIG. 35A is an explodedperspective view of an example base 3502 and a sensor electronics module3550 configured to be secured over or on base 3502, according to someembodiments. FIG. 35B is an exploded perspective bottom view of base3502 and sensor electronics module 3550 of FIG. 35A. FIG. 35C is a planview of a bottom of base 3502 of FIG. 35A. FIG. 35D is a perspectivecutaway view of sensor electronics module 3550 secured to base 3502 ofFIG. 35A.

Analyte sensor system 3500 comprises base 3502 and sensor electronicsmodule 3550. As illustrated, base 3502 and sensor electronics module3550 can each have a substantially circular profile, which allows foromni-directional alignment therebetween. Base 3502 includes a battery3518 configured to power the analyte sensor and/or sensor electronicsmodule 3550. Battery 3518 can be disposed in a cavity through a top sideof base 3502. In some embodiments, battery 3518 may be secured in itscavity utilizing conductive epoxy or another suitable adhesive compound.

Base 3502 can have a raised perimeter 3504 configured to at leastpartially surround sensor electronics module 3550 as sensor electronicsmodule 3550 is physically and/or mechanically coupled to base 3502,thereby guiding sensor electronics module 3550 into position during suchphysical and/or mechanical coupling. In some embodiments, raisedperimeter 2404 can have a substantially circular perimeter. In contrastto base 3402 of FIG. 34, in some embodiments, base 3502 may not includean aperture similar to aperture 3470.

Sensor electronics module 3550 can have a substantially circular outerperimeter or shape that compliments an inner perimeter or shape ofraised perimeter 3504 of base 3550. In contrast to sensor electronicsmodule 3450 of FIG. 34, in some embodiments, sensor electronics module3550 may not have a raised portion similar to raised portion 3405, sincebase 3502 may not include an aperture similar to aperture 3470. However,when sensor electronics module 3550 is secured over a top of base 3502,sensor electronics module 3550 is similarly configured to fit securelywithin raised perimeter 3504 of base 3502. The substantially circularshape and/or perimeter of sensor electronics module 3550 and raisedperimeter 3504 of base 3502 allow for omni-directional mounting ofsensor electronics module 3550 to base 3502.

Base 3502 can further comprise a first sensor contact 3508 and a secondsensor contact 3510, each electrically connected to a respectiveterminal of the analyte sensor, and a first battery contact 3528 and asecond battery contact 3529, each electrically connected to a respectiveterminal of battery 3518. Base 3502 can further comprise a first sealingmember 3524 configured to surround and seal each of first and secondsensor contacts 3508, 3510 and first and second battery contacts 3528,3529 within a first cavity 3520 formed between facing surfaces of base3502 and sensor electronics module 3550 and first sealing member 3524.In some embodiments, first sealing member 3524 can be disposed on asurface of base 3202 facing sensor electronics module 3550, on asidewall of raised perimeter 3504 of base 3202, or both. In someembodiments, base 3502 can further comprise a second sealing member 3525disposed within a perimeter of first sealing member 3524 and around athrough-hole 3540 of base 3202. First and/or second sealing members3524, 3525 can, for example, include overmolded components such asovermolded gaskets, overmolded elastomeric features, and/or ultra-violetcurable silicone.

Base 3502 is further illustrated as including a plurality of conductivecontacts 3566, which can be formed utilizing any suitable process, forexample, laser direct structuring (LDS) of base 3502 or overmolding of aconductive elastomer. Conductive traces 3566 may be utilized toultimately route electrical signals from the analyte sensor to sensorelectronics module 3550 and/or power from battery 3518 to sensorelectronics module 3550 and to the analyte sensor.

Sensor electronics module 3550 can comprise a plurality ofconcentrically-circular contacts 3554 disposed on an inner surfacefacing base 3502. In some embodiments, contacts 3554 may each have asubstantially ring-like form and may each be annularly spaced apart fromone another, which allows contacts 3554 to make electrical contact withrespective ones of first and second sensor contacts 3508, 3510 and firstand second battery contacts 3528, 3529 of base 3502 when sensorelectronics module 3550 is mounted to base 3502. Due to the annular formof each of contacts 3554, it is contemplated that sensor electronicsmodule 3550 can be mounted onto base 3502 in any orientation. Eachcontact 3554 can be configured to make contact with one of sensorcontacts or battery contacts at any point along the respective contact3554. Contacts 3554 can be formed utilizing any suitable process, forexample, laser direct structuring (LDS) of base 3502 or overmolding of aconductive elastomer. Contacts 3554 can include a first signal contactconfigured to make electrical contact with first sensor contact 3508, asecond signal contact configured to make electrical contact with secondsensor contact 3510, a first power contact configured to make electricalcontact with first battery contact 3528, and a second power contactconfigured to make electrical contact with second battery contact 3529.Such first and second power contacts can be configured to receive powerfrom the battery, while such first and second signal contacts can beconfigured to receive the sensor signal from the analyte sensor. In somealternative embodiments, one or both of first and second sealing members3524, 3525 can alternatively be disposed on the same surface, or anadjacent surface, of sensor electronics module 3550 as contacts 3554,facing base 3502, to form first cavity 3520.

Sensor electronics module 3550 can be secured to base 3502 by pressingsensor electronics module 3550 against base 3502 in a directionsubstantially perpendicular to a bottom surface of base 3502 until oneor more retention features of sensor electronics module 3550 snap intoone or more corresponding retaining members of base 3502. In someembodiments, the retaining members of base 3502 may be the same membersor features utilized to secure base 3502 to an applicator (not shown)for initial deployment to the skin of the host. Sensor electronicsmodule 3550 can be decoupled from base 3502 by pulling sensorelectronics module 3550 perpendicularly away from base 3502 whileanchoring base 3502 with sufficient force to cause decoupling.

FIG. 36 is an exploded perspective view of an example base 3602 and asensor electronics module 3650 configured to be secured over or on base3602, according to some embodiments.

Analyte sensor system 3600 comprises base 3602 and sensor electronicsmodule 3650. As illustrated, base 3602 and sensor electronics module3650 can each have a substantially circular profile, which allows foromni-directional alignment therebetween.

Base 3602 can be configured to attach to the skin of the host, forexample, utilizing an adhesive pad 3614, which can be disposed on a backsurface of base 3602. Adhesive pad 3614 can have substantially similarfeatures and function as previously described for adhesive pad 2314 ofFIGS. 23A-23C.

Sensor electronics module 3650 can have a raised perimeter 3604configured to at least partially surround base 3602 as sensorelectronics module 3650 is physically and/or mechanically coupled tobase 3602, thereby guiding sensor electronics module 3650 into positionduring such physical and/or mechanical coupling. In some embodiments,raised perimeter 3604 can have a substantially circular perimeter.Sensor electronics module 3650 can further include an aperture 3670,which, in some embodiments, can have a substantially circular shape.

Base 3602 can have a substantially circular outer perimeter or shapethat compliments the inner perimeter or shape of raised perimeter 3604of sensor electronics module 3650. Base 3602 can further have a raisedportion 3605 having a substantially circular outer perimeter or shapethat compliments an inner perimeter or shape of aperture 3670.Accordingly, when sensor electronics module 3650 is secured over a topof base 3602, base 3602 is configured to fit securely within raisedperimeter 3604 of sensor electronics module 3650 and raised portion 3605is configured to fit securely within aperture 3670. In some embodiments,when properly secured, a top surface of raised portion 3605 may sitsubstantially flush with a top surface of sensor electronics module3650. However, the present disclosure is not so-limited and the topsurface of raised portion 3605 may sit at an elevated or reducedposition compared to the top surface of sensor electronics module 3650.Accordingly, at least some of the substantially circular shapes and/orperimeters of sensor electronics module 3650, raised portion 3605 ofbase 3602, raised perimeter 3604 of sensor electronics module 3650and/or of aperture 3670 allow for omni-directional mounting of sensorelectronics module 3650 to base 3602.

Base 3602 can further comprise a first sensor contact 3608 and a secondsensor contact 3610, each electrically connected to a respectiveterminal of the analyte sensor, and a first battery contact 3628 and asecond battery contact 3629, each electrically connected to a respectiveterminal of a battery (not shown in FIG. 36) disposed within base 3602.Base 3602 can further comprise a first sealing member (not shown in FIG.36 but substantially similar to first sealing member 3724 of FIGS.37A-37D) configured to surround and seal each of first and second sensorcontacts 3608 and first and second battery contacts 3628 within a firstcavity 3620 formed between facing surfaces of base 3602 and sensorelectronics module 3650 and the first sealing member. The first sealingmember can, for example, include an overmolded component such as anovermolded gasket, an overmolded elastomeric feature, and/or anultra-violet curable silicone.

Sensor electronics module 3650 can comprise a plurality ofconcentrically-circular contacts 3654 disposed on an inner surfacefacing base 3602. In some embodiments, contacts 3654 may each have asubstantially ring-like form and may each be annularly spaced apart fromone another. As shown, contacts 3654 may be centered about aperture3670, which allows contacts 3654 to make electrical contact withrespective ones of first and second sensor contacts 3608, 3610 and firstand second battery contacts 3628, 3729 of base 3602 when sensorelectronics module 3650 is mounted to base 3602. Due to the annular formof each of contacts 3654, it is contemplated that sensor electronicsmodule 3650 can be mounted onto base 3602 in any orientation. Eachcontact 3654 can be configured to make contact with one of sensorcontacts or battery contacts at any point along the respective contact3654. Contacts 3654 can be formed utilizing any suitable process, forexample, laser direct structuring (LDS) of base 3502 or overmolding of aconductive elastomer. Contacts 3654 can include a first signal contactconfigured to make electrical contact with first sensor contact 3608, asecond signal contact configured to make electrical contact with secondsensor contact 3610, a first power contact configured to make electricalcontact with first battery contact 3628, and a second power contactconfigured to make electrical contact with second battery contact 3629.Such first and second power contacts can be configured to receive powerfrom the battery, while such first and second signal contacts can beconfigured to receive the sensor signal from the analyte sensor. In somealternative embodiments, the first sealing member (not shown in FIG. 36)can alternatively be disposed on the same surface, or an adjacentsurface, of sensor electronics module 3650 as contacts 3654 facing base3602 to form first cavity 3620.

Sensor electronics module 3650 can be secured to base 3602 by pressingsensor electronics module 3650 against base 3602 in a directionsubstantially perpendicular to a bottom surface of base 3602 until oneor more retention features of sensor electronics module 3650 snap intoone or more corresponding retaining members of base 3602. In someembodiments, the retaining members of base 3602 may be the same membersor features utilized to secure base 3602 to an applicator (not shown)for initial deployment to the skin of the host. Sensor electronicsmodule 3650 can be decoupled from base 3602 by pulling sensorelectronics module 3650 perpendicularly away from base 3602 whilepressing down on raised portion 3605 of base 3602 with sufficient forceto cause decoupling.

An embodiment similar to that described in connection with FIG. 36 isshown in FIGS. 37A-37D and described below. FIG. 37A is an explodedperspective view of an example base 3702 and a sensor electronics module3750 configured to be secured over or on base 3702, according to someembodiments. FIG. 37B is an exploded perspective bottom view of base3702 and sensor electronics module 3750 of FIG. 37A. FIG. 37C is a planview of a bottom of base 3702 of FIG. 37A. FIG. 37D is a side cutawayview of sensor electronics module 3750 secured to base 3702 of FIG. 37A.

Analyte sensor system 3700 comprises base 3702 and sensor electronicsmodule 3750. As illustrated, base 3702 and sensor electronics module3750 can each have a substantially circular profile, which allows foromni-directional alignment therebetween. While not shown in FIGS.37A-35D, base 3702 can comprise an analyte sensor (e.g., analyte sensor104 of FIG. 1, analyte sensor 212 of FIG. 2, analyte sensor 1016 of FIG.10A) configured to generate a sensor signal indicative of an analyte(e.g., glucose) concentration of a host. Base 3702 further comprises abattery 3718 configured to power the analyte sensor and/or sensorelectronics module 3750. Battery 3718 can be disposed in a cavitythrough a top side of base 3702. In some embodiments, battery 3718 maybe secured in its cavity utilizing conductive epoxy or another suitableadhesive compound.

While not shown in FIGS. 37A-37D, sensor electronics module 3750 caninclude sensor electronics (e.g., sensor electronics 106 of FIGS. 1and/or 2) as described herein and may include at least a wirelesstransceiver configured to transmit a wireless signal based at least inpart on the sensor signal generated by the analyte sensor.

Sensor electronics module 3750 can have a raised perimeter 3704configured to at least partially surround base 3702 as sensorelectronics module 3750 is physically and/or mechanically coupled tobase 3702, thereby guiding sensor electronics module 3750 into positionduring such physical and/or mechanical coupling. In some embodiments,raised perimeter 2404 can have a substantially circular perimeter.Sensor electronics module 3750 can further include an aperture 3770,which, in some embodiments, can have a substantially circular shape.

Base 3702 can have a substantially circular outer perimeter or shapethat compliments an inner perimeter or shape of raised perimeter 3704 ofsensor electronics module 3750. Base 3702 can further have a raisedportion 3405 having a substantially circular outer perimeter or shapethat compliments an inner perimeter or shape of aperture 3770.Accordingly, when sensor electronics module 3750 is secured over a topof base 3702, sensor electronics module 3750 is configured to fitsecurely within raised perimeter 3704 of base 3702, while raised portion3705 of base 3702 is configured to fit securely within aperture 3770.The substantially circular shape and/or perimeter of at least some ofsensor electronics module 3750, aperture 3770, raised perimeter 3704 ofsensor electronics module 3750, and raised portion 3705 of base 3702allow for omni-directional mounting of sensor electronics module 3750 tobase 3702.

Base 3702 can further comprise a first sensor contact 3708 and a secondsensor contact 3710, each electrically connected to a respectiveterminal of the analyte sensor, and a first battery contact 3728 and asecond battery contact 3729, each electrically connected to a respectiveterminal of battery 3718. Base 3702 can further comprise a first sealingmember 3724 configured to surround and seal each of first and secondsensor contacts 3708, 3710 and first and second battery contacts 3728,3729 within a first cavity 3720 formed between facing surfaces of base3702 and sensor electronics module 3750 and first sealing member 3724.In some embodiments, first sealing member 3724 can be disposed on asurface of base 3202 facing sensor electronics module 3750, on asidewall of base 3202, or both. In some embodiments, base 3703 canfurther comprise a second sealing member 3725 disposed within aperimeter of first sealing member 3724 and around a sidewall of raisedportion 3705 of base 3702. In some embodiments, base 3702 can furthercomprise a third sealing member 3727 disposed within a perimeter offirst sealing member 3724 and around a through-hole 3740 of base 3202.First, second and/or third sealing members 3724, 3725, 3727 can, forexample, include overmolded components such as overmolded gaskets,overmolded elastomeric features, and/or ultra-violet curable silicone.

Base 3702 is further illustrated as including a plurality of conductivecontacts 3766, which can be formed utilizing any suitable process, forexample, laser direct structuring (LDS) of base 3702 or overmolding of aconductive elastomer. Conductive traces 3766 may be utilized toultimately route electrical signals from the analyte sensor to sensorelectronics module 3750 and/or power from battery 3718 to sensorelectronics module 3750 and to the analyte sensor.

Sensor electronics module 3750 can comprise a plurality ofconcentrically-circular contacts 3754 disposed on an inner surfacefacing base 3702. In some embodiments, contacts 3754 may each have asubstantially ring-like form and may each be annularly spaced apart fromone another, centered about aperture 3770, which allows contacts 3754 tomake electrical contact with respective ones of first and second sensorcontacts 3708, 3710 and first and second battery contacts 3728, 3729 ofbase 3702 when sensor electronics module 3750 is mounted to base 3702.Due to the annular form of each of contacts 3754, it is contemplatedthat sensor electronics module 3750 can be mounted onto base 3702 in anyorientation. Each contact 3754 can be configured to make contact withone of sensor contacts or battery contacts at any point along therespective contact 3754. Contacts 3754 can be formed utilizing anysuitable process, for example, laser direct structuring (LDS) of base3702 or overmolding of a conductive elastomer. Contacts 3754 can includea first signal contact configured to make electrical contact with firstsensor contact 3708, a second signal contact configured to makeelectrical contact with second sensor contact 3710, a first powercontact configured to make electrical contact with first battery contact3728, and a second power contact configured to make electrical contactwith second battery contact 3729. Such first and second power contactscan be configured to receive power from battery 3718, while such firstand second signal contacts can be configured to receive the sensorsignal from the analyte sensor. In some alternative embodiments, one ormore of first, second and/or third sealing members 3724, 3725, 3727 canalternatively be disposed on the same surface, or an adjacent surface,of sensor electronics module 3750 as contacts 3754 facing base 3702 toform first cavity 3720.

Sensor electronics module 3750 can be secured to base 3702 by pressingsensor electronics module 3750 against base 3702 in a directionsubstantially perpendicular to a bottom surface of base 3702 until oneor more retention features of sensor electronics module 3750 snap intoone or more corresponding retaining members of base 3702. In someembodiments, the retaining members of base 3702 may be the same membersor features utilized to secure base 3702 to an applicator (not shown)for initial deployment to the skin of the host. Sensor electronicsmodule 3750 can be decoupled from base 3702 by pulling sensorelectronics module 3750 perpendicularly away from base 3702 whilepushing down on raised portion 3705 of base 3702 with sufficient forceto cause decoupling.

Slider Embodiments

FIGS. 38A-39C illustrate several embodiments of analyte sensor systemsin which a base includes a rail along which a sensor electronics module,having a channel configured to accommodate the rail, can be slid overand secured onto the base.

While not shown in FIGS. 38A-39C, bases 3802-3902 can comprise ananalyte sensor (e.g., analyte sensor 104 of FIG. 1, analyte sensor 212of FIG. 2, analyte sensor 1016 of FIG. 10A) configured to generate asensor signal indicative of an analyte (e.g., glucose) concentration ofa host, while sensor electronics modules 3850-3950 can include sensorelectronics (e.g., sensor electronics 106 of FIGS. 1 and/or 2) asdescribed herein and may include at least a wireless transceiverconfigured to transmit a wireless signal based at least in part on thesensor signal generated by the analyte sensor.

In some embodiments, an analyte sensor base assembly may include base3802-3902 configured to attach to a skin of a host and one or more ofthe analyte sensor as described above and configured to generate asensor signal indicative of an analyte concentration level of the host,at least one battery at least as will be described below, at least onesensor contact 3808-3908 and/or 3810-3910, at least one battery contact3828-3938 and/or 3829-3929, a sealing member 3824-3924 and/or 3925configured to provide a seal around at least the at least one batterycontact 3828-3938 and/or 3829-3929, and/or any other features associatedwith and/or configured to couple with base 3802-3902 at least asdescribed below.

FIG. 38A is a perspective view of an example base 3802 and a sensorelectronics module 3850 configured to be slid over and secured to base3802, according to some embodiments. FIG. 38B is a perspective view ofsensor electronics module 3850 secured to base 3802 of FIG. 38A.Discussion follows with respect to FIGS. 38A-38B below.

As shown in the figures, analyte sensor system 3800 comprises base 3802and sensor electronics module 3850. Base 3802 can be configured toattach to the skin of the host, for example, utilizing an adhesive pad3814, which can be disposed on a back surface of base 3802. Adhesive pad3814 can have substantially similar features and function as previouslydescribed for adhesive pad 2314 of FIGS. 23A-23C.

In some embodiments, base 3802 can be configured to slide over andphysically and/or mechanically couple with sensor electronics module3850 utilizing one or more retaining features. For example, base 3802can have a raised central rail 3872 configured to guide sensorelectronics module 3850 into position during physical and/or mechanicalcoupling to base 3802. In some embodiments, rail 3872 can have asubstantially constant width along its length. However, the presentdisclosure is not so limited and rail 3872 can have a width that tapersalong its length such that rail 3872 is substantially wedge-shaped,having a first width at a first end of rail 3872 and a second widthsmaller than the first width at a second end of rail 3872 opposite thefirst end. Such a tapered width of rail 3872 may facilitate easy matingof sensor electronics module 3850 with base 3802 and a good seal aroundone or more components and/or electrical contacts disposed thereon.Sensor electronics module 3850 can further comprise a channel 3874having a shape that compliments an outer perimeter or shape of rail 3872of base 3802.

While not shown in FIGS. 38A-38B, to accomplish, affect and/or supportsuch physical and/or mechanical coupling, base 3802 can further includeat least one of a first and a second retaining member (e.g., see atleast retaining members 3944 of FIG. 39A-39C), while sensor electronicsmodule 3850 can further include at least one of a first and a secondretention feature (e.g., see at least retention features 3956 of FIG.39A-39C) configured to mate with the first and second retaining members,respectively. Such at least one retaining member(s) and retentionfeature(s) can prevent sensor electronics module 3850 from undesirablybacking out from the secured position with respect to base 3802, asshown in FIG. 38, and as further described in connection with FIGS.39A-39C below.

FIG. 38A illustrates base 3802 as having a first sensor contact 3808 anda second sensor contact 3810, each electrically coupled to a respectiveterminal of the analyte sensor, and a first battery contact 3828 and asecond battery contact 3829, each electrically coupled to a respectiveterminal of a battery (not shown in FIGS. 38A-38B but see e.g., battery3918 of FIGS. 39A-39C).

Sensor electronics module 3850 can comprise a plurality of contacts 3854disposed on an inner surface of channel 3874. In some embodiments,contacts 3854 can include a first signal contact configured to makeelectrical contact with first sensor contact 3808, a second signalcontact configured to make electrical contact with second sensor contact3810, a first power contact configured to make electrical contact withfirst battery contact 3828 and a second power contact configured to makeelectrical contact with second battery contact 3829. Such first andsecond power contacts can be configured to receive power from thebattery, while such first and second signal contacts can be configuredto receive the sensor signal from the analyte sensor.

Base 3802 can further include a first sealing member 3824 configured tosurround and seal first and second sensor contacts 3808, 3810, first andsecond battery contacts 3828, 3829, the first and second signal contactsand the first and second power contacts within a first cavity 3820.While first sealing member 3824 is illustrated as being disposed on asidewall of rail 3874, the present disclosure is not so limited andfirst sealing member 3824 could alternatively be disposed on an innersurface of channel 3874 of sensor electronics module 3850, surroundingcontacts 3854, and similarly configured to form first cavity 3820.

Sensor electronics module 3850 can be secured to base 3802 by aligningchannel 3874 of sensor electronics module 3850 with rail 3872 of base3802 and sliding sensor electronics module 3850 in a direction parallelto the host's body until sensor electronics module 3850 reaches the endof its travel along rail 3872, is seated against at least a portion ofbase 3802, and the at least one retaining member(s) and retentionfeature(s) (not shown in FIGS. 38A-38B) are engaged with one another. Insome embodiments, such aligning and securing of sensor electronicsmodule 3850 to base 3802 can be accomplished by the host with a singlehand, having at least one finger against base 3802 and at least oneother finger against sensor electronics module 3850 and pressing thefingers closer to one another until sensor electronics module 3850 isproperly secured to base 3802.

An embodiment similar to that described in connection with FIGS. 38A-38Bis shown in FIGS. 39A-39C and described below. FIG. 39A is a perspectiveview of an example base 3902 and a sensor electronics module 3950configured to be slid over and secured to base 3902, according to someembodiments. FIG. 39B is another perspective view of base 3902 of FIG.39A. FIG. 39C is an exploded perspective bottom view of base 3902 andsensor electronics module 3950 of FIG. 39A. Discussion follows withrespect to FIGS. 39A-39C below.

As shown in the figures, analyte sensor system 3900 comprises base 3902and sensor electronics module 3950. Base 3902 is configured to receive abattery 3918 within a cavity in a bottom surface of base 3902. Base 3902can also include a cover 3960 configured to be attached to and/ordisposed on a bottom side of base 3902. Cover 3960 may be shaped andsized to secure battery 3918 within base 3902. Cover 3960 can be securedto the bottom surface of base 3902 utilizing any suitable method, forexample, snaps, adhesive, friction fittings, heat-staking, and/or laser,heat or ultra-sonic welding along weld line 3912.

As shown in FIG. 39B, base 3902 can comprise a plurality of conductivetraces 3966, which can be formed utilizing any suitable process, forexample, laser direct structuring (LDS) of base 3902 or overmolding of aconductive elastomer. Conductive traces 3966 may be utilized toultimately route electrical signals from the analyte sensor to sensorelectronics module 3950 and/or power from battery 3918 to sensorelectronics module 3950 and to the analyte sensor.

Base 3902 further includes a first sensor contact 3908 and a secondsensor contact 3910, each electrically coupled to a respective terminalof the analyte sensor in base 3902 via at least some of conductivetraces 3966. Contacts 3908, 3910 can be disposed immediately adjacent toone another. Base 3902 further includes a first battery contact 3928 anda second battery contact 3929, each electrically coupled to a respectiveterminal of battery 3918 via at least some other of conductive traces3966 on cover 3960. Contacts 3928, 3929 can be similarly disposedimmediately adjacent to one another. Contacts 3908, 3910, 3928, 3929 areillustrated as being disposed on a sidewall of base 3902 and configuredto face a mating surface of sensor electronics module 3950. However, thepresent disclosure is not so-limited and contacts 3908, 3910, 3928, 3929can be disposed on any suitable surface of base 3902. Contacts 3908,3910, 3938, 3929 can comprise conductive elastomeric contacts (e.g.pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces,or any other suitable conductive materials and/or structures.

Base 3902 further includes a sealing member 3924, which can extend overand thereby seal conductive traces 3966 and which also surrounds andcreates a single continuous seal around contacts 3908, 3910 to form afirst cavity 3920 a, and another single continuous seal around contacts3928, 3929 on base 2302 to form a second cavity 3920 b. Sealing member3924 can, for example, include an overmolded component such as anovermolded gasket, an overmolded elastomeric feature, and/or anultra-violet curable silicone that may be coupled to a surface of base3902 utilizing any suitable method.

Sensor electronics module 3950 can comprise a plurality of contacts 3954disposed on a surface (e.g., a sidewall) of sensor electronics module3950 configured to face the mating surface of sensor electronics module3950 on which contacts 3908, 3910, 3928, 3929 are disposed. Contacts3954 can comprise conductive elastomeric contacts (e.g. pucks), springs,tabs, posts, pogo pins, flat conductive pads or traces, or any othersuitable conductive materials and/or structures. In some embodiments,contacts 3954 can include a first signal contact configured to makeelectrical contact with first sensor contact 3908, a second signalcontact configured to make electrical contact with second sensor contact3910, a first power contact configured to make electrical contact withfirst battery contact 3928 and a second power contact configured to makeelectrical contact with second battery contact 3929. Such first andsecond power contacts can be configured to receive power from battery3918, while such first and second signal contacts can be configured toreceive the sensor signal from the analyte sensor.

In some embodiments, base 3902 can be configured to slide over andphysically and/or mechanically couple with sensor electronics module3950 utilizing one or more retaining features. For example, base 3902can have a raised central rail 3972 configured to guide sensorelectronics module 3950 into position during physical and/or mechanicalcoupling to base 3902. In some embodiments, rail 3972 can have asubstantially constant width along its length. However, the presentdisclosure is not so limited and rail 3972 can have any suitable shape,width or widths along its length. To accomplish, affect and/or supportsuch physical and/or mechanical coupling, base 3902 can further includeat least one retaining member 3944. Retaining member(s) 3944 cancomprise snaps, hooks, deflectable tabs or any other suitable type ofretaining member(s).

Sensor electronics module 3950 can further comprise a channel 3974having a shape that compliments an outer perimeter or shape of rail 3972of base 3902, and at least one retention feature 3956 configured to matewith retaining member(s) 3944. In some embodiments, retention feature(s)3956 can comprise recesses configured to accept retaining member(s)3944. Such retaining member(s) 3944 and retention feature(s) 3956 cansubstantially immobilize sensor electronics module 3950 to base 3902 andprevent sensor electronics module 3950 from undesirably backing out fromsuch a secured position.

In some embodiments, base 3902 can have a break line 3964 defining afirst portion of base 3902, on which retaining member(s) 3944 aredisposed, from a second portion of base 3902 disposed on an oppositeside of break line 3964 from the first portion. Accordingly, the firstportion of base 3902 can comprise a frangible tab configured to separatefrom the second portion of base 3902 along break line 3964 when thefirst portion of base 3902 is sufficiently bent, flexed or otherwisedeflected from its resting position shown in FIG. 39A, and similar tothat previously described in connection with FIGS. 24A-24D.

Sensor electronics module 3950 can be secured to base 3902 by aligningchannel 3974 of sensor electronics module 3950 with rail 3972 of base3902 and sliding sensor electronics module 3950 in a direction parallelto the host's body until sensor electronics module 3950 reaches the endof its travel along rail 3972, is seated against at least a portion ofbase 3902, and retaining member(s) 3944 and retention feature(s) 3956are engaged with one another. In some embodiments, such aligning andsecuring of sensor electronics module 3950 to base 3902 can beaccomplished by the host with a single hand, having at least one fingeragainst base 3902 and at least one other finger against sensorelectronics module 3950 and pressing the fingers closer to one anotheruntil sensor electronics module 3950 is properly secured to base 3902.

Methods of Manufacture Related to the Above-Described Embodiments

Several example methods of fabricating disposable analyte sensor baseshaving one or more batteries disposed therein and reusable sensorelectronics modules configure to releasably couple to the bases areprovided below in connection with FIG. 40.

The methods disclosed herein comprise one or more steps or actions forachieving the described methods. The method steps and/or actions may beinterchanged with one another without departing from the scope of theclaims. In other words, unless a specific order of steps or actions isspecified, the order and/or use of specific steps and/or actions may bemodified without departing from the scope of the claims.

An example method 4000 for fabricating an analyte sensing apparatusand/or system will now be described in connection with FIG. 40 below.Method 4000 may correspond at least to the previous description inconnection with FIGS. 1-39C.

Block 4002 includes forming a base configured to attach to a skin of ahost. For example, a base can be formed according to the descriptionrelated to at least any of bases 1002-3902 as previously described inconnection with any of FIGS. 10A-39C.

Block 4004 includes disposing a first plurality of contacts on the base.For example, any of bases 2302-3902 can have disposed thereon at least afirst plurality of contacts including first sensor contact 2308-3908 andsecond sensor contact 2310-3910, as previously described in connectionwith FIGS. 23A-39C. In some embodiments, the first plurality of contactscan further include first battery contact 2328-3228, 3428-3828 andsecond battery contact 2329-3229, 3429-3829, as previously described inconnection with FIGS. 23A-32 and 34-38B.

Block 4006 includes attaching an analyte sensor to the base, the analytesensor configured to generate a sensor signal indicative of an analyteconcentration level of the host. For example, analyte sensor 104 can beattached to any of at least bases 2302-3902. As previously described,analyte sensor 104 is configured to generate a sensor signal indicativeof an analyte concentration level of the host.

Block 4008 includes attaching a battery to the base. For example, abattery, such as any battery described in connection with at least FIGS.10A-39C, can be attached to the respective base 1002-3902, as previouslydescribed in connection with at least FIGS. 10A-39C.

Block 4010 includes forming a sensor electronics module configured toreleasably couple to the base, the sensor electronics module comprisinga wireless transceiver configured to transmit a wireless signal based atleast in part on the sensor signal. For example, a sensor electronicsmodule can be formed according to the description related to at leastany of sensor electronics modules 2350-3950 as previously described inconnection with any of FIGS. 23A-39C.

Block 4012 includes disposing a second plurality of contacts atrespective locations on the sensor electronics module such that each ofthe second plurality of contacts is configured to make electricalcontact with a respective one of the first plurality of contacts whenthe sensor electronics module is secured to the base. For example, anyof sensor electronics modules 2350-3950 can have disposed thereon atleast a second plurality of contacts 2354-3954, including a first signalcontact configured to make electrical contact with first sensor contact2308-3908 and a second signal contact configured to make electricalcontact with the second sensor contact 2310-3910 when sensor electronicsmodule 2350-3950 is secured to base 2302-3902, as previously describedin connection with FIGS. 23A-39C. In some embodiments, the secondplurality of contacts 2354-3954 can further include a first powercontact configured to make electrical contact with first battery contact2328-3228, 3428-3828 and a second power contact configured to makeelectrical contact with second battery contact 2329-3229, 3429-3829 whensensor electronics module 2350-3950 is secured to base 2302-3902, aspreviously described in connection with FIGS. 23A-32 and 34-38B.

Block 4014 includes disposing a first sealing member on one of the baseand the sensor electronics module, the first sealing member configuredto form a first cavity and provide a continuous seal around the firstand second plurality of contacts within the first cavity when the sensorelectronics module is secured to the base. For example, first sealingmember 2324-3924 can be disposed on at least one of base 2302-3902 andsensor electronics module 2350-3950, as previously described inconnection with at least FIGS. 23A-39C, such that first sealing member2324-3924 is configured to form a first cavity 2320-3920 and provide acontinuous seal around the first and second plurality of contacts withinfirst cavity 2320-3920 when sensor electronics module 2350-3950 issecured to base 2302-3902.

In some embodiments, base 2302-3902 is configured to be disposable. Insome embodiments, sensor electronics module 2350-3950 is configured tobe reusable. In some embodiments, the battery is configured to providepower to analyte sensor 104 and to sensor electronics module 2350-3950.In some embodiments, the first and second signal contacts are configuredto receive the sensor signal via first 2308-3908 and second 2310-3910sensor contacts and the first and second power contacts are configuredto receive power from the battery when sensor electronics module2350-3950 is secured to base 2302-3902. In some embodiments, each ofsecond plurality of contacts 2654 are in direct electrical contact withone of analyte sensor 104 and the battery.

In some embodiments, method 4000 may further comprise electricallycoupling first 2308-3908 and second 2310-3910 sensor contacts torespective terminals of analyte sensor 104. In some embodiments, method400 may further comprise electrically coupling first battery contact2328-3228, 3428-3828 and second battery contact 2329-3229, 3429-3829 torespective terminals of the battery.

In some embodiments, method 4000 may further comprise forming a firstretaining member 2342-3942 and a second retaining member 2344-3944 onbase 2302-3902, and forming, on sensor electronics module 2350-3950, afirst retention feature 2352-3952 configured to mate with firstretaining member 2342-3942 and a second retention feature 3956configured to mate with the second retaining member 2344-3944 whensensor electronics module 2350-3950 is secured to base 2302-3902,thereby releasably coupling sensor electronics module 2350-3950 to base2302-3902. In some embodiments, second retaining member 2344-3944 isfrangible and configured to be separable from base 2302-3902. In someembodiments, second plurality of contacts 2854-2954 are disposed onfirst retention feature 2852, 2952. In some embodiments, first retainingmember 2842, 2942 comprises a hood and the first plurality of contacts2908, 2910, 2928, 2929 are disposed within the hood. In someembodiments, first sealing member 2824 is disposed around acircumference of securement feature 2852 such that first cavity 2820 isdisposed within the hood. In some embodiments, first sealing member 2924is disposed on an inner surface of the hood.

In some embodiments, method 4000 may further comprise securing cover2460, 2560, 2960, 3160, 3360, 3960 to a bottom of base 2402, 2502, 2902,3160, 3360, 3902. Such a cover can be configured to secure the batterywithin the respective base. In some embodiments, method 4000 may furthercomprise disposing a first plurality of conductive traces 2466, 3166,3366, on cover 2460, 3160, 3360 such that at least some of firstplurality of contacts are coupled to one of analyte sensor 104 and thebattery via first plurality of conductive traces 2466, 3166, 3366 whencover 2460, 3160, 3360 is secured to the bottom of base 2402, 3102,3302.

In some embodiments, method 4000 may further comprise disposing a firstplurality of conductive traces 2366, 2566-2666, 2866-3066, 3466-3966 onbase 2302, 2502-2026, 2802-3002, 3402-3902 such that at least some ofthe first plurality of contacts are electrically coupled to one ofanalyte sensor 104 and the battery via first plurality of conductivetraces 2366, 2566-2666, 2866-3066, 3466-3966. In some embodiments, firstsealing member 2524-2624, 2924, 3824-3924 extends over first pluralityof conductive traces 2566-2666, 2966, 3866-3966, thereby sealing firstplurality of conductive traces 2566-2666, 2966, 3866-3966 from moistureingress. In some embodiments, first sealing member 2666 extends overbattery 2618, thereby sealing battery 2618 from moisture ingress.

In some embodiments, method 4000 may further comprise forming anaperture 3070-3170, 3670-3770 in sensor electronics module 3050-3150,3650-3750, and forming a raised portion 3005-3105, 3605-3705 on base3002-3102, 3602-3702 configured to fit within aperture 3070-3170,3670-3770, wherein an outer perimeter of the raised portion complimentsan inner perimeter of the aperture. In some embodiments, first pluralityof contacts 3008, 3010, 3028, 3029 are disposed on raised portion 3005.In some embodiments, aperture 3070-3170 is symmetrical about at leastone axis parallel to a top surface of sensor electronics module3050-3150 and asymmetrical about at least one other axis parallel to thetop surface of sensor electronics module 3050-3150. In some embodiments,the battery is disposed within raised portion 3005-3105, 3605 of base3002-3102, 3602. In some embodiments, a top surface of raised portion3005-3105, 3605-3705 sits substantially flush with a top surface ofsensor electronics module 3050-3150, 3650-3750 when the sensorelectronics module is secured to base 3002-3102, 3602-3702.

In some embodiments, method 4000 may include forming a recess 3242-3342in a top surface of base 3202-3302 and forming a protrusion 3252-3352configured to mate with recess 3242-3342 such that mating of protrusion3252-3352 with recess 3242-3342 aligns sensor electronics module3250-3350 for securing with base 3202-3302.

In some embodiments, method 4000 may further comprise forming a thirdplurality of contacts on base 3302, 3902, forming a fourth plurality ofcontacts at locations on sensor electronics module 3350, 3950 such thateach of the fourth plurality of contacts is configured to makeelectrical contact with a respective one of the third plurality ofcontacts when sensor electronics module 3350, 3950 is secured to base3302, 3902, and disposing a second sealing member 3325, 3925 on one ofbase 3302, 3902 and sensor electronics module 3350, 3950. Second sealingmember 3325, 3925 is configured to form a second cavity 3320 b, 3920 band provide a continuous seal around the third and fourth plurality ofcontacts within the second cavity when sensor electronics module 3350,3950 is secured to base 3302, 3902. In some embodiments, the thirdplurality of contacts comprises first battery contact 3328, 3928 andsecond battery contact 3329, 3929. In some embodiments, method 4000further comprises electrically coupling first 3328, 3928 and second3329, 3929 battery contacts to respective terminals of the battery. Insome embodiments, fourth plurality of contacts 3354, 3954 comprises afirst power contact configured to make electrical contact with firstbattery contact 3328, 3928 and a second power contact configured to makeelectrical contact with second battery contact 3329, 3929 when sensorelectronics module 3350, 3950 is secured to base 3302, 3902.

In some embodiments, second plurality of contacts 3454-3754 compriseconcentric, circular contacts. In some embodiments, concentric, circularcontacts 3454-3754 are disposed around a center of sensor electronicsmodule 3450-3750. In some embodiments, each of second plurality ofcontacts 3454-3754 are configured to make electrical contact with therespective one of the first plurality of contacts when sensorelectronics module 3450-3750 is secured to base 3402-3702 in any of aplurality of radial orientations.

In some embodiments, method 4000 may further comprise forming anaperture 3470 in base 3402 and forming a raised portion 3405 on sensorelectronics module 3450 configured to fit within aperture 3470, whereinan outer perimeter of raised portion 3405 compliments an inner perimeterof aperture 3470. In some embodiments, aperture 3470 and raised portion3405 each have a substantially circular shape.

In some embodiments, method 4000 may further comprise forming raisedrail 3872-3972 on base 3802-3902 and forming channel 3874-3974 having ashape that compliments a shape of raised rail 3872-3972 on sensorelectronics module 3850-3950. In some embodiments, raised rail 3872-3972can have a constant width along its length. In some embodiments, a widthof raised rail 3872-3972 tapers along its length. In some embodiments,first plurality of contacts 3808, 3810, 3828, 3829 are disposed on asidewall of raised rail 3872 and second plurality of contacts 3854 isdisposed on a sidewall of channel 3874. In some embodiments, first3908,3910 and third 3928, 3929 plurality of contacts are disposed on asidewall of base 3902 and the second and fourth plurality of contacts3954 are disposed on a sidewall of sensor electronics module 3950.

Each of these non-limiting examples can stand on its own or can becombined in various permutations or combinations with one or more of theother examples.

The above detailed description includes references to the accompanyingdrawings, which form a part of the detailed description. The drawingsshow, by way of illustration, specific embodiments in which theinvention can be practiced. These embodiments are also referred toherein as “examples.” Such examples can include elements in addition tothose shown or described. However, the present inventors alsocontemplate examples in which only those elements shown or described areprovided. Moreover, the present inventors also contemplate examplesusing any combination or permutation of those elements shown ordescribed (or one or more aspects thereof), either with respect to aparticular example (or one or more aspects thereof), or with respect toother examples (or one or more aspects thereof) shown or describedherein.

In the event of inconsistent usages between this document and anydocuments so incorporated by reference, the usage in this documentcontrols.

In this document, the terms “a” or “an” are used, as is common in patentdocuments, to include one or more than one, independent of any otherinstances or usages of “at least one” or “one or more.” In thisdocument, the term “or” is used to refer to a nonexclusive or, such that“A or B” includes “A but not B,” “B but not A,” and “A and B,” unlessotherwise indicated. In this document, the terms “including” and “inwhich” are used as the plain-English equivalents of the respective terms“comprising” and “wherein.” Also, in the following claims, the terms“including” and “comprising” are open-ended, that is, a system, device,article, composition, formulation, or process that includes elements inaddition to those listed after such a term in a claim are still deemedto fall within the scope of that claim. Moreover, in the followingclaims, the terms “first,” “second,” and “third,” etc. are used merelyas labels, and are not intended to impose numerical requirements ontheir objects.

Geometric terms, such as “parallel”, “perpendicular”, “round”, or“square”, are not intended to require absolute mathematical precision,unless the context indicates otherwise. Instead, such geometric termsallow for variations due to manufacturing or equivalent functions. Forexample, if an element is described as “round” or “generally round”, acomponent that is not precisely circular (e.g., one that is slightlyoblong or is a many-sided polygon) is still encompassed by thisdescription.

Method examples described herein can be machine or computer-implementedat least in part. Some examples can include a computer-readable mediumor machine-readable medium encoded with instructions operable toconfigure an electronic device to perform methods as described in theabove examples. An implementation of such methods can include code, suchas microcode, assembly language code, a higher-level language code, orthe like. Such code can include computer readable instructions forperforming various methods. The code may form portions of computerprogram products. Further, in an example, the code can be tangiblystored on one or more volatile, non-transitory, or non-volatile tangiblecomputer-readable media, such as during execution or at other times.Examples of these tangible computer-readable media can include, but arenot limited to, hard disks, removable magnetic disks, removable opticaldisks (e.g., compact disks and digital video disks), magnetic cassettes,memory cards or sticks, random access memories (RAMs), read onlymemories (ROMs), and the like.

The above description is intended to be illustrative, and notrestrictive. For example, the above-described examples (or one or moreaspects thereof) may be used in combination with each other. Otherembodiments can be used, such as by one of ordinary skill in the artupon reviewing the above description. The Abstract is provided to complywith 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain thenature of the technical disclosure. It is submitted with theunderstanding that it will not be used to interpret or limit the scopeor meaning of the claims. Also, in the above Detailed Description,various features may be grouped together to streamline the disclosure.This should not be interpreted as intending that an unclaimed disclosedfeature is essential to any claim. Rather, inventive subject matter maylie in less than all features of a particular disclosed embodiment.Thus, the following claims are hereby incorporated into the DetailedDescription as examples or embodiments, with each claim standing on itsown as a separate embodiment, and it is contemplated that suchembodiments can be combined with each other in various combinations orpermutations. The scope of the invention should be determined withreference to the appended claims, along with the full scope ofequivalents to which such claims are entitled.

What is claimed is:
 1. An analyte sensor base assembly, comprising: abase configured to attach to a skin of a host; an analyte sensorconfigured to generate a sensor signal indicative of an analyteconcentration level of the host; at least one battery; at least onesensor contact; at least one battery contact; and a sealing memberconfigured to provide a seal around at least the at least one batterycontact.
 2. The assembly of claim 1, wherein the sealing member isfurther configured to provide the seal around at least the at least onesensor contact.
 3. The assembly of claim 1, comprising at least twosensor contacts and at least two battery contacts, wherein the sealingmember is configured to provide the seal around the at least two sensorcontacts and the at least two battery contacts.
 4. The assembly of claim1, wherein the base further comprises a plurality of conductive tracesconfigured to electrically connect the battery to the at least onebattery contact.
 5. The assembly of claim 1, wherein the base furthercomprises a plurality of conductive traces configured to electricallyconnect the analyte sensor to the at least one sensor contact.
 6. Theassembly of claim 1, wherein the assembly is disposable.
 7. The assemblyof claim 1, wherein the battery is configured to provide power to theanalyte sensor and to a sensor electronics module that is couplable tothe base.
 8. The assembly of claim 1, wherein the base further comprisesa first retaining member configured to mate with a securement feature ofa couplable sensor electronics module; and a second retaining memberconfigured to mate with a retention feature of the couplable sensorelectronics module.
 9. The assembly of claim 8, wherein the secondretaining member is frangible and configured to be separable from thebase.
 10. The assembly of claim 8, wherein the base further comprises acover configured to secure to the base and configured to secure thebattery within the base.
 11. The assembly of claim 8, wherein the firstretaining member comprises a hood and the at least one sensor contactand the at least one battery contact are disposed within the hood. 12.The assembly of claim 11, wherein the sealing member is disposed withinthe hood.
 13. The assembly of claim 1, wherein the sealing member is anovermolded elastomer.